Science/R&D

Eli Lilly and Company

Senior/Principal Scientist – Peptide Technical Services & Manufacturing Science (TS/MS), API

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization Overview:**

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Senior or Principal Scientist will join the Technical Services/Manufacturing Sciences (TS/MS) team who work within a dynamic external manufacturing environment to provide technical support and scientific expertise across Peptides and Oligonucleotides (TIDES). The Senior/Principal Scientist acts as an SME responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners, process team members and site management.

The candidate will be responsible for technical transfer, process stewardship, process monitoring and will demonstrate a proactive attitude to issue resolution. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers. The incumbent would preferably possess an investigative mindset and be skilled at critical thinking with a preference for collaborative working.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.

**Key Objectives/Deliverables:**

- Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes.
- Leads resolution of technical issues including those related to control strategy and manufacturing.
- Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs.
- Build and maintain relationships with development partners and central technical organizations.
- Ensure proper characterization of processes and ensure effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability.
- Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify any leading signals of process weakness from yield/quality standpoint and proactively resolve/escalate.
- Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
- Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks in place. Demonstrate a structured approach to problem solving and investigation.
- Support regulatory submissions with technical input as required, author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices.
- Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place.
- Maintaining peptide/oligonucleotide processes in a state of compliance with US and global regulations
- Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
- Operate with ‘Team Lilly’ in mind - including coaching and mentoring of peers and other scientists.

**Basic Requirements:**

- Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred)
- 3+ years of demonstrated experience with pharmaceutical manufacturing and working knowledge of regulatory expectations.
- *Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.*

**Additional Preferences:**

- Knowledge and experience with Regulatory requirements
- Enthusiasm for changes, team spirit and flexibility
- Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
- Proficiency in delivering complex tasks and/or tasks that are cross-functional
- Demonstrated Project Management skills and ability to coordinate complex projects

**Additional Information**

- Some travel (\<25%) is required
- Some off-shift work (night/weekend) may be required to support 24/7 operations
- **This position is located onsite in Indianapolis, IN and is not approved for remote work.**

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Director - Clinical Research Physician - GPS Medical

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Clinical Research Physician, GPS Medical

**Purpose**

The Clinical Research Physician (CRP) in GPS Medical has responsibilities associated with the development, management, execution, and oversight of all aspects of the safety program for one (or more) asset(s) throughout the product(s’) life cycle. This individual plays a major role in coordinating technical functions within GPS to facilitate these responsibilities. The individual is accountable for collaborative contributions and partnership with the integrated development or product team to deliver on these safety commitments while demonstrating GPS expertise and leadership.

The CRP is the Lilly GPS Medical representative for both internal and external stakeholders regarding a product or developmental therapeutic agent, interacting as prescribed in corporate guidelines, standards, and policies. Individualized responsibilities for a particular product or project will be discussed and agreed at an individual level.

**Primary Responsibilities**

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Not all listed responsibilities will be applicable to all GPS Medical CRP roles.

1. Key GPS Medical Activities and Safety Oversight

▪ Provides GPS Medical leadership and ensures proactive pharmacovigilance (PV) for assigned product(s):

i. In early phase development, performs and/or contributes to medical review of individual case safety reports for completeness and accuracy, providing company causality assessment and requests for follow up, if needed.

ii. Provides medical oversight of surveillance activities, safety signal decisions and risk management actions to be taken, including communication and/or escalation to appropriate internal or external stakeholders (e.g., GPS leadership, governance committees, development teams, Regulators)

iii. Monitors various safety activities for impact to Core Safety Information and Core Risk Minimization activities i

v. Builds collaborative working relationships to ensure full cooperation; guides effective and efficient drug development, and ensures high-quality medical evaluation of safety data

v. Responsible for the oversight and actions related to regulatory queries on safety-related topics

▪ Acts as the GPS Medical lead at the time of acquisitions and integrations of new companies/assets, partnering with internal and external stakeholders to ensure seamless continuity of safety surveillance activities.

▪ Demonstrates advanced knowledge of safety concepts, per ICH, US and international regulation/guidelines and GxP.

▪ Synthesizes complex data into actionable insights and translates technical issues into strategic discussions

2. Acts as the Lilly GPS Medical Representative for both internal and external stakeholders, interacting as prescribed in corporate guidelines and policies.

▪ Builds strong relationships with key stakeholders, representing and championing the role of safety in the organization (including):

i. Product Team Leaders and Business Unit Leadership

ii. Regulatory (including Device and CMC regulatory)

iii. Affiliate Medical Leadership/Clinical Research Physicians

iv. COE and Discovery and Clinical Research

v. External Opinion Leaders

▪ Reviews and comments on external regulatory policy and trends affecting Global Patient Safety.

▪ Represents GPS Medical in inspection and audit activities for assigned program(s)

▪ May serve on safety advisory hub committees and/or consultative cross-functional bodies providing input and guidance to clinical development teams on select safety topics

▪ May serve as a member of the Quality-GPS (AE/PC and Device) safety surveillance teams evaluating aggregate product complaint/adverse event data for potential manufacturing quality related safety signals

3. Product Safety Assessment

• Provide the sound and timely medical assessment decision making for the safety questions based on current medical and scientific data in collaboration with cross-functional partners for the following:

i. Product Safety Assessments (PSAs), Health Hazard Evaluations (HHEs), and other risk assessment documentation

ii. Device design, development, risk management, and periodic reporting

iii. CMC development, manufacturing changes, CMC submissions and CMC regulatory requests,

iv. Company anticounterfeiting activities, product shortage evaluations, quality triage escalation activities and regulatory reporting.

▪ Provide clinical evaluation of individual adverse events for possible manufacturing-related root cause for Lilly products

▪ Responsible for appropriate implementation of PSA/HHE process with manufacturing and/or marketing partners.

▪ Prepare medical complaints in response to signals identified during AE/PC and Device Surveillance.

▪ Review and approve/reject manufacturing investigation results in response to medical complaints, including escalation as needed for any identified manufacturing related safety issues.

▪ Proactive monitoring to evaluate for unanticipated safety impacts related to deviations addressed by HHEs

4. People Management

▪ Foster and support a collaborative working environment that maintains a Team Lilly culture focused on inclusion, innovation, acceleration, and delivery

▪ Recruit, mentor, develop, and retain top clinical, scientific, and drug development talent, including clinical research physicians, clinical research scientists, and pharmacoepidemiologists.

▪ Assures staff comply with company policies and procedures

5. Understand and support the QPPV role

▪ Understanding the roles and responsibilities of the European Union Qualified Person (QPPV).

▪ Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.

6. Training, Coaching, Mentoring

▪ Provide training, coaching and mentorship demonstrating effective PV strategies and sharing experience and knowledge to further advance the goals of the GPS department and wider enterprise.

▪ Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum.

▪ Maintaining compliance with the Lilly Corporate Integrity Agreement.

7. A Clinical Research Physician, GPS Medical is expected to meet the criteria as outlined in the global path job criteria for the appropriate R path levels.

▪ For each level on every global path, there is a consistent set of job criteria which includes functional and technical expertise, decision making, influence, and problem solving.

**Minimum Qualification Requirements:**

▪ Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.

▪ US trained physicians must have achieved board eligibility or certification. Foreign medical graduates (in US based jobs) who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.

▪ Non-US trained physicians must have completed education and training at a medical school that meets the minimum requirements substantially equivalent to the requirements of medical schools accredited by the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see[PLA: Physicians Licensing Information and Medical Education](<http://www.in.gov/pla/2799.htm>) | MBC

▪ Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting.

**Other Information/Additional Preferences:**

▪ Prior experience in clinical trials preferred; academic and/or industry.

▪ Clinical development or pharmacovigilance experience preferred

▪ Knowledge of drug development process

▪ Fluent in English with highly effective written and verbal communication skills

▪ Strong clinical/diagnostic skills

▪ Excellent interpersonal, organizational and negotiation skills

▪ Ability to work on multiple projects and function effectively in a fast-paced matrixed environment

▪ Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines

▪ Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment

▪ Excellent teamwork skills

▪ Willing to engage in domestic and international travel to the degree appropriate to support the business of the team

▪ Knowledge of global pharmacovigilance guidelines, guidance, and regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above Strategic thinking

▪ Demonstrated success in implementing projects and/or innovating

▪ Receptive, engaging, and impactful contributor

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$201,000 - $360,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Director, Medical - Clinical Research Scientist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Cardiometabolic Research (CMR) Program Clinical Research Scientist (CRS) participates in the following for compounds of responsibility for the therapeutic area, including an evolving portfolio of compounds targeting women’s health: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contacts with regulatory and other governmental agencies; assessment of licensing opportunities, and the outreach activities aimed at the external clinical customer community. In addition, the Clinical Research Scientist works with research scientists to identify lead compounds and clinical candidates and plan pre-clinical studies. Core tasks will be delegated based on level of experience.

Other activities include internal training activities, peer-review of clinical protocols and reports, and ad hoc scientific consultation within Lilly. The CRS works with late stage development colleagues to plan for meeting patient needs through clinical studies, and outcomes and pharmacoeconomic research.

**Responsibilities:**

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. The primary responsibilities of the CMR Program Phase CRS are generally related to early-phase compounds, including those targeting women’s health.

The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.

Clinical Planning

- Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision. Support preparation of high-level plan for phase Ill studies.
- Collaborate with local clinical research staff, consultants and clinical investigators in the design, conduct and reporting of global Phase lb and Ila/IIb clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions).
- Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug­ disease response models.
- Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development.
- Collaborate with non-clinical pharmacologists to translate observations from animal experiments to human clinical studies (biomarker development) in the area therapeutic area of responsibility.
- Collaborate with drug disposition scientist to conduct pharmacokinetic and drug metabolism studies of drug candidates in humans.
- Assist pharmacokineticists and statisticians by providing clinical support to the development of pharmacostatistical models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens and selection of the target patient population.

Clinical Research/Trial Execution and Support

- Design and oversee implementation of Phase lb and Ila/IIb clinical studies.
- Design and write clinical trial protocols.
- Design and oversee implementation methods for development and biomarker qualification studies.
- Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements.
- Participate in investigator identification and selection, in conjunction with clinical team.
- Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials (Phase I and II).
- Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects.
- Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
- Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
- Serve as resource to CDAs I clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
- Understand and actively address the scientific information needs of all investigators and personnel.
- Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.

Scientific Data Dissemination/Exchange

- Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers.
- Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- Consider, review or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects.
- Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Participate in data analysis, development of scientific data dissemination and preparation of final reports.
- Support development of slide sets and publications (abstracts, posters, manuscripts).
- Support the creation and review of any scientific information with respect to customer questions or media request in accordance with global compliance policies and procedures.
- Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).

Regulatory Support Activities

- Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response.
- Develop and review labeling modifications in collaboration with regulatory and safety groups.
- Participate in risk management planning along with GPS colleagues.
- Provide medical expertise to regulatory scientists.

Business/ customer support

- Understand the scientific/medical needs of all CMR Program Phase customers (payers, patients, health care providers
- Provide advice and consultation to global business unit with regard to potential markets for development compounds and in-licensed projects or compounds.
- Support business development in collaboration with the regulatory and corporate affairs group.
- Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis.
- Participate in PhRMA or other local or national trade associations.
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Participate in patent development.
- Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert.

Scientific & Technical Expertise and Continued Development

- Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area.
- Provide consultation to health outcomes staff, marketing professionals, and management regarding the potential medical need served by responsible therapeutic area drug candidates.
- Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects.
- Explore and take advantage of opportunities for extramural scientific experiences.
- Attend scientific symposia.
- Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule.
- Maintain awareness of current clinical practices through experience or contacts.

**General Responsibilities**

- Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers.
- Actively participate in recruitment, diversity, and retention efforts.
- Participate in committees, initiatives and task forces as requested by local/corporate management.
- Model leadership behaviors and lead matrixed cross-functional teams.
- Be an ambassador of both patients and for the Lilly Brand.

**Basic Qualifications/Requirements:**

- PhD in a relevant field (i.e Endocrinology, Reproduction, Internal medicine, Development Biology, Immunology, Cell Biology, Physiology, Pharmacology, Neuroscience)
- 5+ years clinical development experience.

**Additional Information :**

- Clinical research or pharmaceutical medicine experience preferred.
- Knowledge of drug development process preferred.
- Fluent in English; both written and verbal communications.
- Interpersonal, organizational and negotiation skills.
- Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Excellent teamwork skills.
- Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$177,000 - $338,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Lundbeck

Scientist I - Downstream Process Development

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to advance brain health and transform lives.

**Position Summary:**

The Scientist I is a part of the Downstream Process Development team. This collaborative team develops processes for therapeutic biologic candidates in preclinical, clinical, and late-stage development. The primary responsibility will be to develop scalable and robust purification processes that produce protein within targeted product quality profile for clinical and commercial scales. This individual plays a synergistic role within downstream group and will collaborate extensively with members of upstream, analytical and formulation development groups.

**Essential Functions:**

- Designs, executes, and interprets complex downstream process development studies supporting clinical and commercial biologics programs.
- Serves as a subject matter expert in downstream processing, with particular emphasis on Chromatography, Ultrafiltration/diafiltration (UF/DF), Depth filtration, Viral inactivation and Viral filtration.
- Apply strong experimental design principles to develop efficient, scientifically rigorous studies that address process performance, robustness, and scalability.
- Independently analyses complex experimental datasets, identify trends and risks, and translate results into clear technical conclusions and recommendations.
- Authors and reviews technical reports, development documents, presentations, protocols, and other documentation supporting process development activities.
- Presents scientific strategy, experimental results, recommendations, and technical risks to project teams and senior stakeholders.
- Serves as the Downstream Process Development functional-area lead on cross-functional development programs.
- Partners with Manufacturing and other technical functions to support process scale-up and technology transfer to internal or external manufacturing facilities.
- Provides technical support during manufacturing implementation, including troubleshooting and resolution of process-related issues.
- Collaborates effectively across organizational and geographic boundaries while maintaining clear communication and strong follow-through.

**Required Education, Experience, and Skills**

- Bachelor’s degree and 8+ years’ experience in biopharmaceutical industry or Masters and 6 years’ experience, or PhD and 0-2 years’ experience or relevant combination of education and experience.
- Extensive knowledge of the scientific principles and practical execution of protein purification using column chromatography and filtration techniques including UF/DF, depth filtration, viral inactivation, and viral filtration.
- Demonstrated ability to independently design scientifically rigorous experiments and interpret complex datasets.
- Skilled in Unicorn-based AKTA programming and result evaluation.

**Preferred Education, Experience, and Skills**:

- BS or advanced degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Biochemistry, or a related scientific or engineering discipline.
- Experience supporting late-stage process development, process characterization, validation readiness, or commercial process development.
- Familiarity with viral clearance for early and late-stage programs.
- Experience supporting technology transfer activities, including preparation of process descriptions, transfer documentation, risk assessments, and manufacturing support.
- Hands-on experience with pilot-scale downstream processing equipment and operations.
- Familiarity with process characterization, scale-down model qualification, and establishment of proven acceptable ranges or process operating ranges.
- Experience supporting regulatory filings or responding to technical questions related to downstream process development.
- Demonstrated experience leading a functional area on a cross-functional development program and/or leading complex technical project teams.
- Ability to effectively coordinate activities across multiple functions, communicate priorities, identify risks, and drive decisions.
- Excellent verbal and written communication skills, including the ability to communicate complex technical concepts to both technical and non-technical audiences.
- Strong organizational and project-management skills, with demonstrated ability to manage multiple priorities and deliverables.

**Travel Requirements:**

- Domestic and international travel up to 20% may be required.

The range displayed is specifically for those potential hires who will work or reside in the state of Washington, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $135,000 - $155,000 and eligibility for a 10% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and company match 401k. Additional benefits information can be found on our [site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>). Applications accepted on an ongoing basis. #LI-LM1

**Why Lundbeck**

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the [U.S. career site](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf>).

*Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the* [*U.S. career site*](<https://www.lundbeck.com/us/careers/your-job/eeo-accommodations-policy>).

*Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in* [*E-Verify*](<https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/E-Verify_Participation_Poster_Eng_Es.pdf>).

Washington

Associate Director, Lab Operations

**The Opportunity:**

Reporting to the Director of Laboratory Operations, as the **Associate Director, Laboratory Operations**, you will provide leadership for laboratory operations within the Knoxville Laboratory and is responsible for overall operational performance, quality, compliance, staffing, and resource management across laboratory functions and shifts. You will lead Managers, Senior Managers, and operational support leaders to ensure the laboratory meets safety, quality, service, financial, and operational goals. You will work closely with the Director, Quality, Validation, Human Resources, Facilities, IT, and other business partners to support a safe, compliant, and efficient operation while preparing the laboratory for future growth.

**The Role:**

**_Strategic Execution & Performance Management_**

- Translate lab-wide goals into actionable plans for assigned departments; establish KPIs and lead performance reviews to ensure goal achievement.
- Monitor and manage Laboratory Operations Key Performance Indicators (KPIs).
- Implement course corrections to achieve goals and contribute to monthly operational reports and presentations.

**_Operational Excellence & Process Optimization_**

- Lead initiatives to improve lab efficiency, throughput, and quality, including infrastructure upgrades and system enhancements.
- Analyze operational data to identify trends, diagnose root causes, and implement corrective actions to improve lab performance.
- Manage day-to-day capacity and organizational capability to perform high-volume testing required for the release of plasma per customer specifications.

**_Regulatory Compliance & Quality Oversight_**

- Ensure adherence to FDA, CLIA, cGMP, and internal SOPs; maintain inspection readiness and lead corrective/preventive actions.
- Ensure laboratory operations comply with all relevant regulatory agencies (FDA, CLIA, GHA, etc.). Maintain an "inspection-ready" condition at all times, drive corrective/preventive actions (CAPA), and ensure staff are trained in current SOPs.

**_Leadership & Talent Development_**

- Leads and develops Managers, Senior Managers, and operational leaders.
- Oversees staffing plans, succession planning, leadership development, employee relations, and workforce planning to support current and future operational needs.

**_Financial & Capital Management_**

- Supports development of operating budgets, staffing plans, and resource requirements.
- Monitors financial performance and works with laboratory leadership to ensure resources are aligned with operational demands and business priorities.

**_Cross-Functional Collaboration_**

- Partners with Quality, Validation, Human Resources, Facilities, IT, Engineering, and other business partners to support laboratory operations, implement improvements, and address operational challenges.

**_Stakeholder Engagement & Industry Relations_**

- Serves as a key representative for laboratory operations.
- Builds effective working relationships with internal and external stakeholders and supports business continuity, benchmarking, customer service, and operational planning activities.

**_Safety & Facility Oversight_**

- Promote a culture of safety and compliance; ensure facility maintenance meets operational and regulatory standards.
- Maintain a clean, efficient, and safe work environment.
- Ensure strict adherence to Environmental Health and Safety (EHS), OSHA, and Standard Operating Procedures (SOPs).

**_Change Leadership & Innovation_**

- Leads major operational changes that affect laboratory functions, staffing, workflows, systems, or business processes.
- Supports implementation of new technologies, equipment, and operational improvements while ensuring organizational readiness and adoption.

**Your Skills & Abilities:**

- Bachelor’s degree in chemical, biological, or clinical laboratory science, or medical technology from an accredited institution required.
- Medical Technologist preferred.
- Minimum of 8 years of relevant laboratory experience, including at least 4 years of leadership experience in a laboratory, healthcare, manufacturing, pharmaceutical, biologics, or other regulated environment.
- **Regulatory Knowledge:**  Demonstrated working knowledge of FDA regulations, including GMP, GLP, and CLIA standards.
- **Financial Acumen:**  Experience monitoring departmental budgets and managing resource allocations.
- **Leadership & Communication:**  Proven ability to manage, motivate, and develop supervisory teams. Strong written, verbal, and presentation skills to effectively communicate metrics and drive operational results.
- **Problem Solving:**  Excellent critical reasoning and analytical skills to resolve recurring operational defects and manage shifting priorities under tight deadlines.

**Key Leadership Competencies**

- Strategic thinking
- Operational leadership
- Organizational effectiveness
- Change management
- Cross-functional collaboration
- Continuous improvement mindset
- Quality and Regulatory focus

**Working Conditions:**

- Ability to compute, analyze, and interpret operational data and statistical forecasts.
- Fast-paced environment with frequent interruptions.
- Frequently sitting, with a moderate amount of time walking the laboratory floor and standing.
- Must be able to wear personal protective equipment (PPE) and tolerate occasional exposure to extreme temperatures and bloodborne pathogens. Ability to lift/carry up to 40 lbs.
- Overnight travel required up to 15–20% of the time.
- **Schedule Flexibility:**  Ability to work a flexible schedule, including weekends, evenings, and holidays, to provide operational oversight across all 7 days of operation and multiple shifts.
- **Operational Availability:**  Maintains operational accountability for a 7-day (24/6) high-volume testing environment, requiring occasional visibility and presence on alternate shifts to support leadership teams and manage critical escalations.

*Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.*

**About CSLPlasma**

[CSL Plasma](<https://www.cslplasma.com/>)operates one of the world’s largest and most sophisticated plasma donation networks,with nearly 330 donation centers in the U.S. and Europe. CSL Plasma is a subsidiary of CSL, a global biopharma company. Plasma collected at CSL Plasma facilities is used by CSL for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company,[CSL](<https://www.csl.com/>)(ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 29,000+ people.

Learn more about CSL Plasma here [https://www.cslplasma.com/](<https://www.cslplasma.com/>) and CSL, CSL Behring, CSL Seqirus and CSL Vifor here [https://www.csl.com/](<https://www.csl.com/>).

Learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor here at [https://www.csl.com/](<https://www.csl.com/>) and CSL Plasma at [https://www.cslplasma.com/](<https://www.cslplasma.com/>).

**Our Benefits**

For more information on CSL Plasma benefits visit [https://cslbenefits.com/cslp](<https://cslbenefits.com/cslp>).

**You Belong at CSL**

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more visit https://www.csl.com/careers/inclusion-and-belonging

**Equal Opportunity Employer**

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit [https://www.csl.com/accessibility-statement](<https://www.csl.com/accessibility-statement>).

Tennessee

Amgen

Scientist, Integrated Computational and Experimental Inflammation Discovery

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Scientist, Integrated Computational and Experimental Inflammation Discovery**

**What you will do**

Lets do this. Lets change the world. In this vital role, you will contribute to Inflammation discovery programs by personally designing and executing wet-lab studies and applying computational and AI-enabled approaches to analyze and integrate omics data.

You will connect these insights with experimental findings to deepen our understanding of disease biology, prioritize therapeutic targets, and develop and test mechanistic hypotheses in the laboratory. Working with minimal supervision, you will manage defined program components, develop an area of scientific expertise, and communicate data-driven insights that help advance project decisions.

Key Responsibilities:

- Plan and coordinate defined project tasks and activities that support target identification, validation, and progression of Inflammation discovery programs.
- Design, execute, analyze, and interpret bench/wet lab studies to investigate disease mechanisms and test therapeutic hypotheses with scientific rigor and appropriate urgency.
- Apply computational, AI-enabled, and data-analytic approaches to generate mechanistic insights, refine experimental design, and integrate findings across data sources.
- Integrate experimental results with published literature, human genetics, clinical observations, and internal or external datasets to inform ongoing project design.
- Develop and optimize solutions to technical problems of advanced scope and complexity within an emerging area of expertise.
- Collaborate across functions and departments, contributing at the project-team level and building constructive relationships with wet-lab, computational, translational, and drug-discovery partners.
- Organize, interpret, document, and present project data and scientific recommendations within work groups, project teams, and internal scientific forums.
- Coach or guide others within the work group or project team where appropriate, and contribute to a collaborative culture of scientific curiosity, knowledge sharing, and operational excellence.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The researcher we seek is a Scientist with these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 2 years of experience in Immunology, Cell Biology, Molecular Biology, Pharmacology, Biomedical Sciences, Computational Biology, Bioengineering

OR

Bachelors degree and 4 years of experience in Immunology, Cell Biology, Molecular Biology, Pharmacology, Biomedical Sciences, Computational Biology, Bioengineering

**Preferred Qualifications:**

- Demonstrated hands-on experience independently designing, executing, troubleshooting, and interpreting wet-lab experiments to investigate inflammation biology and validate therapeutic hypotheses.

- Strong grounding in inflammation and immunology, with the ability to translate computational insights into testable hypotheses and follow-up laboratory studies.

- Experience analyzing spatial transcriptomics data and/or integrating multimodal omics datasets to investigate disease mechanisms and inform target discovery.

- Hands-on proficiency in Python or R for omics data analysis and visualization, including the ability to critically evaluate analytical methods and outputs from AI-enabled tools and computational workflows.

- Ability to work independently and manage defined project components.

- Strong scientific communication and cross-functional collaboration skills.

**What you can expect from us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

California

BAI Senior Manager, Global Oncology Forecasting Lead

**JOIN AMGENS MISSION OF SERVING PATIENTS**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**BAI Senior Manager, Global Oncology Forecasting Lead**

**What you will do**

Lets do this. Lets change the world. The Forecasting team at Amgen plays a pivotal role as a strategic partner to commercial leadership, offering data-backed insights crucial for driving commercial success. This role is instrumental in driving commercial success and shaping future strategies for our oncology pipeline assets. The Global Oncology Forecasting Lead will be responsible for leading the forecasting efforts for pipeline assets and diseases within the Global Oncology business unit.

The individual in this role will work with individual product/brand forecasters to develop cross-brand insights, ensure quality/consistency, drive adoption of best practices, coach & mentor junior forecasters, and help distill forecasting analytics into concise, executive worthy strategic recommendations for the brand team.

As part of these duties, the individual will need to strategically influence and challenge a diverse set of collaborators from Commercial, R&D, Medical, Finance, Manufacturing, Access, and Pricing/Contracting, while proficiently understanding the nuances of the particular disease area and relevant markets.

This role reports to the Senior Director of Global Forecasting and operates within the broader framework of Global Customer Capabilities & Innovation (GCCI). The role will be responsible for the following:

**Strategic Insights and Recommendations:**

- Support leadership in identifying actionable strategies to improve commercial potential and prioritize key risks & opportunities.
- Provide informed recommendations & rationale on product go / no-go decisions based on relevant factors such as market conditions, financial projections, and strategic goals.
- Present forecast recommendations and insights to leadership in a concise, straightforward manner, centered on business dynamics rather than modeling nuances.

**Communication and Presentation:**

- Work with product/brand forecasting leads to deliver transparent presentations articulating the key forecast variables and revenue implications.
- Develop brand & portfolio-level analyses & recommendations appropriate for a VP level audience.
- Use communication and interpersonal skills to help shape key brand decisions and recommended course of action.

**Advanced Forecasting Techniques:**

- Support & coach forecasters on the development of detailed and advanced forecast models projecting units and revenue for our oncology pipeline products by indication/regions
- Use advanced simulation models (e.g., Monte Carlo analysis, statistical trending) to quantify uncertainty within a brand and across the Global Oncology portfolio
- Leverage in-depth knowledge of diverse pharmaceutical data sources (e.g., LAAD, National Audit Rx, Xponent, Epidemiology data sources, etc.) and their nuances to enhance forecasting approaches and methodologies
- Lead methodology & best practice development and ensure consistency across multiple brand forecasts
- Lead roll-out of novel centralized forecasting platform.

**Collaboration and Stakeholder Engagement:**

- Collaborate with the broader BAI organization to ensure product/brand forecasters have access to comprehensive insights and analytics relevant to their work
- Improve the depth and accuracy of forecasts by leveraging a broad spectrum of insights across the organization
- Explore AI/ML and automation; identify team capability gaps and build skills
- Owns multi-brand forecasts; challenges entrenched assumptions; drives process improvements across cycles

**Process Optimization:**

- Drive productivity and efficiency by standardizing forecasting processes where possible
- Oversee deliverables across brands/assets and ensure quality.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The forecasting professional we seek is a leader with these qualifications.

Flexible Commuter role to Thousand Oaks office. **You will be expected to work on-site 2 days a week**.

**Basic Qualifications:**

Doctorate degree and 2 years of Pharma/Biotech forecasting, demand planning, or supply chain management experience

OR

Masters degree and 4 years of Pharma/Biotech forecasting, demand planning, or supply chain management experience

OR

Bachelors degree and 6 years of Pharma/Biotech forecasting, demand planning, or supply chain management experience

OR

Associates degree and 10 years of Pharma/Biotech forecasting, demand planning, or supply chain management experience

OR

High school diploma / GED and 12 years of Pharma/Biotech forecasting, demand planning, or supply chain management experience

**Preferred Qualifications:**

- Prior experience in oncology
- 6+ years of forecasting, market research, or business analytics experience in the biopharmaceutical or healthcare industries
- Ability to quickly establish credibility with and influence ED/VP level staff
- Strong project management skillsable to organize and complete multiple projects efficiently and on time
- Understanding of the latest developments in the biopharmaceutical industry, and unmet medical needs and opportunities in oncology
- Experience with advanced forecasting techniques, patient based forecast modeling (including dynamic patient flow models), and experience doing analog and uptake curve analysis
- Experience with quantitative techniques including smoothing, regression, time series analysis, and simulation
- Working knowledge of forecasting inputs and structure, global access and reimbursement policies, competitive environment and potential impact on product development and commercialization strategy
- Broad, working knowledge of commonly used biopharmaceutical industry databases such as IQVIA, Symphony Health, Flatiron, EMR, Optum, Truven, McKesson, DRG and other large datasets that require custom analysis and evaluation
- Highly skilled in working collaboratively in a team-based environment and gaining alignment across an organization
- High level of proficiency in Excel, PowerPoint, Word
- Excellent communication skills with the ability to present complex data and insights to both technical and non-technical partners, including senior management
- Ability to interpret and analyze data trends, identify patterns, and make data-driven decisions
- Experience in contributing to the development of long-term business plans based on forecasting insights

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Administrative Coordinator - Rare Disease Business Unit

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Administrative Coordinator- Rare Disease Business Unit**

**What you will do**

Lets do this. Lets change the world. In this vital role you will provide comprehensive and high-level administrative support to the Executive Director, Patient Access and Executive Director, Hub Services within the Rare Disease Business Unit Patient Access organization. This role requires exceptional organizational skills, strong attention to detail, and the ability to handle multiple priorities in a fast-paced, dynamic environment. The AC will partner closely with internal stakeholders and external collaborators to ensure seamless operations and efficient coordination of departmental activities.

**Responsibilities:**

Manage complex calendars for multiple Executive Directors, with a focus on efficient time utilization, resolution of scheduling conflicts, and appropriate executive representation at required forums across multiple time zones.

Coordinate business travel logistics, including flights, hotels, ground transportation, and timely processing of expense reports.

Apply and maintain knowledge of Amgen policies and procedures related to travel, onsite meetings, purchasing, and administrative support activities.

Support preparation and scheduling for programs and meetings owned by multiple executives, including recurring meetings, all-staff meetings, and other large forums.

Coordinate logistics for large meetings, including room setup, AV support, catering, and related onsite or virtual meeting needs.

Prepare and coordinate team communications, including new-hire announcements and other business updates.

Manage and support special projects, event coordination, and team-building activities in both virtual and face-to-face settings.

Maintain accurate and current distribution lists.

Maintain accurate and current organizational charts.

Order office supplies and manage related purchasing activities through MyBuy or other approved systems, as needed.

Schedule interviews and coordinate related logistics, as needed.

Demonstrate proficiency in established office technology platforms, including Outlook, Microsoft Teams, Concur, MyBuy, and SharePoint, with a demonstrated interest in adopting emerging AI tools, such as ChatGPT, to improve efficiency, communication, and administrative workflows.

Manage multiple priorities effectively in a fast-paced, dynamic environment.

Maintain the highest standards of confidentiality, integrity, and discretion in handling sensitive information.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is someone with these qualifications

**Basic Qualifications:**

Associates degree and 2 years of administrative experience OR

2 years in a technical school setting with hands-on experience OR

High school diploma / GED and 4 years of administrative experience

**Preferred Qualifications:**

Strong attention to detail

Ability to multi-task

Proficiency in MS Office/PowerPoint programs

Excellent verbal and written communication skills.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

**Ready to Apply for the Job?**

We highly recommend utilizing Workday's robust **Career Profile** feature to complete the application process. A link to update your profile is available when you click **Apply**. You can then complete your Workday profile in minutes with the Upload My Experience functionality to upload an updated copy of your resume or you can simply edit the individual sections of your Career Profile.

Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a Partially Meets Expectations or higher. Please visit our [Internal Transfer Guidelines](<https://amgennow.service-now.com/people_self_service?id=kb_article&sysparm_article=KB0061732>) for more detailed information

District of Columbia

Thought Leader Liaison-Rare Disease (Uplizna) Neurology

Territory: Arizona

Relocation is not offered for this role.

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Thought Leader Liaison - Rare Disease (Uplizna)**

**What you will do**

Lets do this. Lets change the world! This critical role is a customer-facing role responsible for executing the customer aspects of the Neuroimmunology Business Units peer to peer strategies and building productive relationships with speakers, thought leaders and other key influencers from key accounts in their assigned geography. The Thought Leader Liaison (TLL) is responsible for engaging compliantly with key thought leaders in neuroimmunology and neuromuscular disease. This role works cross-functionally with Sales, Site of Care, and Medical Affairs to address customer needs and drive collaboration.

Responsibilities include:

- Significant customer-facing time, building relationships with existing and new thought leaders for involvement in current and future commercial activities
- Creates local peer to peer strategies in coordination with national and regional strategic marketing and sales business plans.
- Collaborates closely with the Amgen advocacy team to develop relationships with key physician and patient organization
- Creates and executes short term and long-term KOL engagement plans.
- Captures, synthesizes and shares key thought leader insights to help shape brand strategy and prepare for future life cycle management and competitor entry into the marketplace
- Identifies evidence gaps across product and disease education through appropriate thought leader discussions and podium observations.
- Disseminate thought leader insights to broader Amgen stakeholders, including marketing, sales, market access to drive development of new strategies and tactical approaches and to ensure a comprehensive view of market trends is integrated into overall planning
- Coordinate leadership interactions at all assigned national/regional, state society conferences
- Initiates and pursues opportunities to involve Amgen in meaningful programs with thought leaders to ensure Amgen is strategically and strongly positioned in the market
- Assists with speaker events, including selection of speakers, training for speakers and reviewing current speaker programs ensuring consistent messaging and compliant execution
- Collaborates with marketing team on peer-to-peer programs including speaker training programs and contributes to ongoing refinement of U.S. speaker bureau
- Contributes to content development by providing customer insight and perspective, increasing program impact & relevance

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The marketing professional we seek is a collaborative partner with these qualifications.

**Basic Qualifications:**

- Doctorate degree and 2 years of marketing or sales experience OR
- Master's degree and 4 years of marketing or sales experience OR
- Bachelor's degree and 6 years of marketing or sales experience OR
- Associates degree and 10 years of marketing or sales experience OR
- High school diploma / GED and 12 years of marketing or sales experience

**Preferred Qualifications:**

- Customer facing pharmaceutical or biotech industry experience (field sales, product marketing, medical or clinical experience in the same or related therapeutic area) is required
- Experience in the neurology, neuroimmunology and neuromuscular disease.
- Clinical experience in rare diseases or specialty biologics strongly preferred
- Thought leader or demonstrated KOL leadership experience a plus
- Proven track record of consistent achievement or exceeding expectations in assigned responsibilities, goals, objectives and any other relevant metrics, especially involving cross functional matrix teams
- Previous experience in multiple commercial functions beneficial
- Demonstrated experience customizing and executing timely action plans across various initiatives
- Demonstrates leadership, strategic agility and persuasive aptitude
- Exceptional ability to collaborate and/or lead cross functional teams
- Ability to present ideas effectively by consolidating and customizing information
- Strong organizational, analytic and time management planning skills
- Exceptional clinical/business acumen

**Travel Requirements:**

- Willingness to travel, inclusive of conferences on weekends, overnight programs as well as attendance at key internal meetings
- Individual must reside within territory boundaries given travel requirements

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Arizona

Process Development Senior Scientist

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Process Development Senior Scientist**

**What you will do**

Lets do this. Lets change the world. In this vital role you will join Amgens Pivotal Drug Product Technologies group in Thousand Oaks, CA. The group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgens Late-Stage biologics portfolio.

The ideal candidate will bring hands-on experience in biologics drug product formulation and co-formulation, with experience across multiple modalities, including enzymes, monoclonal antibodies (mAbs), and peptides. The candidate will have a strong understanding of protein attributes,stability and process-related degradation pathways, and analytical strategies for characterizing critical quality attributes (CQAs). This role will integrate formulation, analytical, and process data to guide product design and development. The successful candidate willapplyinnovativetechnologies, including AI and machine learning where appropriate, and collaborate across functions to deliver high-quality, stable, and manufacturable drug products in a fast-paced environment.

- Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
- Design, plan, complete, and document formulation and process development studies
- Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
- Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
- Develop and characterize liquid formulations for biologics, with particular emphasis on enzyme drug product formulation or co-formulations
- Build process understanding across unit operations to support scalable drug productdevelopment
- Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making
- Author/review guideline documents, technical protocols and reports, risk assessments, and regulatory sections in support of IND and marketing application submissions
- Provide support to clinical and commercial technology transfer activities and manufacturing operations through process fit assessments, process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
- Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
- Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs
- Lead cross functional initiatives enhancing drug product platforms and contribute to process design improvement projects

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

**Basic Qualifications:**

Doctorate degree PhD OR PharmD OR MD \[and relevant post-doc where applicable\]

OR

Masters degree and 3 years of Scientific experience

OR

Bachelors degree and 5 years of Scientific experience

**Preferred Qualifications:**

- PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or related field with 24 years of postdoc or industry experience
- Experience integrating formulation, stability, and analytical data to advance biologics including enzyme, mAb and peptide candidates is highly desirable
- Demonstrated understanding of biologics drug product development considerations, including protein stability, degradation pathways, quality attributes, and product/process comparability
- Experience developing or characterizing enzymes, including assessment of activity, stability, and performance under relevant formulation or process conditions
- Experience in formulation and co-formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
- Strong foundationin analytical and biophysical techniques relevant to biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.)
- Experience with programming, application of AI-enabled tools as well as data visualization tools (e.g. Tableau, Spotfire)
- Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs)
- Strong project management skills, including the ability to manage ones project resources (material, workforce, time, etc.)
- Critical thinking, problem solving and independent research skills
- Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Sr Medical Science Liaison, Uncontrolled Gout - Rare Disease - South FL/Puerto Rico

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Sr. Medical Science Liaison, Uncontrolled Gout - Rare Disease - South Florida/Puerto Rico**

**Territory to include Miami, Tampa, Orlando, Puerto Rico**

**What you will do**

Lets do this. Lets change the world. In this vital role you will serve as a scientific liaison to the medical/scientific community and will be responsible for establishing, developing and maintaining relationships with prominent experts and clinicians throughout the US.

- Network and partner with important external customers, including medical thought leaders, academic institutions, large group practices, medical directors, managed care decision makers, and pharmacy directors in alignment with applicable compliance, legal, and regulatory guidelines.
- Understand, integrate and effectively communicate scientific/medical information and commercial value of products to the medical community and other key internal and external audiences.
- Prioritize and work effectively in a self-directed manner in a constantly changing environment, including ability to obtain, integrate, and communicate customer feedback.
- Pair customers unmet needs with available internal resources.
- Collaborate effectively with all functional areas to identify opportunities and needs that can be addressed via communication of scientific, medical, and health economic information.
- Identify potential new speakers and train on scientific content for sponsored external speaker programs.
- Participate in national and regional conferences, meetings, and other scientific venues as appropriate to support the Medical/Clinical strategy and to obtain new competitive information, keep abreast of clinical trends, and support and maintain relationships with key investigators and scientific research.
- Working in conjunction with the medical affairs and clinical development teams, evaluate potential external clinical research collaboration opportunities and facilitate the conduct of external clinical investigator-initiated trials (IITs) and company-sponsored trials.
- Monitor the competitive environment for advances and trends in our therapeutic areas, including new treatment management and new therapies, as well as competitive products and features and provide feedback to the senior leadership team on specific initiatives of competitors.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a self starter with these qualifications.

**Basic Qualifications:**

- Doctorate degree

OR

- Masters degree & 3 years of Medical Affairs experience

OR

- Bachelors degree & 5 years of Medical Affairs experience

**Preferred Qualifications:**

- Pharm.D., Ph.D., M.D. or D.O. (other doctoral degrees considered)
- 2 years of proven experience in scientific or medical affairs at a biotech or pharmaceutical company
- 2+ years of experience in a Medical Science Liaison role
- Exceptional oral and written communication and interpersonal skills (including strong demonstration of ability to network) required.
- Ability to travel up to 60% for territory management, attendance at regional and national conferences/workshops, and attendance at company meetings.
- There may be a need to work up to 15-hour days due to travel
- Must have ability to learn to use new business applications across hardware tools (e.g., PC, iPad).
- Proficient in Microsoft Office.
- Professional, proactive demeanor.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Florida

Case Manager - Rare Disease- TEPEZZA - Central US- Remote

Job Description

**HOW MIGHT YOU DEFY IMAGINATION?**

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

**Live**

**What you will do**

Lets do this. Lets change the world. In this vital role the Case Manager will experience day to day oversight and awareness of patient customer service issues with insurance, the specialty pharmacy, and patient support programs

- Daily interaction with Regional Business Managers (RBMs), Patient Access Liaison (PAL) and Medical Science Liaisons (MSLs) to ensure current and accurate communication on the status of insurance approvals and reauthorizations
- Work closely with RBMs, PALs, the hub, pharmacy, and the patient/family to case manage all steps required to gain access to therapy
- Partner with Safety and Pharmacovigilance (PV). Report Adverse Event (AE)s and product complaints through medical information
- Maintain case history for all U.S. patients, entering relevant notes from the hub, the pharmacy, calls to insurance, patient support programs, physicians and nurses, and the patients and families
- Maintain and update patient status to track reimbursement and shipping status of U.S. patients
- Triage, troubleshoot and resolve initial and ongoing reimbursement issues (PAs, denials, appeals, reauthorizations, overrides, billing problems)
- Liaise with medical offices as necessary to obtain insurance authorizations
- Counsel patients and family on insurance and reimbursement options
- Identify general and specic adherence trends and suggest appropriate action
- Report on weekly changes in patient status, current adjudication status of all patients, overall reimbursement trends, and any other trends, successes, or roadblocks
- Manage, track, and report on Open Enrollment efforts annually to ensure every patient has

access to adequate insurance

- Advise patients and families on insurance, nancial assistance and therapeutic access

programs

- Attend patient meetings, industry conferences and sales meetings

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a \[type of person\] with these qualications.

**Basic Qualications:**

Masters degree OR

Bachelors degree and 2 years of Case Management experience Or

Associates degree and 6 years of Case Management experience Or

High school diploma / GED and 8 years of Case Management experience

**Preferred Qualications:**

- Bachelors Degree strongly preferred
- 5+ years of experience in the pharmaceutical industry
- 2+ years prior experience as a Case Manager
- Excellent communication skills and commitment to customer service
- Ability to effectively resolve hurdles across multiple cases at the same time
- Ability to learn product and disease information, familiarity with HIPAA and FDA
- Ability to manage communication with case managers and sales reps across multiple geographies and time zones
- Excel and PowerPoint skills required
- Up to 20% travel required

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, nancial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

- Comprehensive employee benets package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and exible spending accounts.
- A discretionary annual bonus program, or for eld sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible

**Apply now**

**for a career that dees imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

Amgen anticipates accepting until 11/15/2026 however, we will continue accepting

applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benets and privileges of employment. Please contact us to request accommodation.

Sr Data Scientist

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Data Scientist (GCCI)

**Sr Data Scientist**

\*Flexible Commuter role to Deerfield, IL site. You will work on-site a minimum of 2 days a week.

**What you will do**

Lets do this. Lets change the world. In this vital role as part of the Data Sciences team in Global Customer Capabilities & Innovation, the Senior Data Scientist will partner with commercial insights and analytics, brand teams, sales operations, data teams, external vendor partners, media agencies, service owners, and IS partners to develop advanced analytics and data science solutions that address complex business problems across multiple therapeutic areas and commercial functions. This individual will independently lead analytical workstreams, apply deep technical expertise to large and complex healthcare datasets, develop and productionize machine learning and AI solutions, and translate sophisticated analyses into clear, actionable business recommendations. The Senior Data Scientist will also contribute technical leadership, methodological standards, and mentorship across the team.

**Specific roles and responsibilities could include:**

Leading the development and application of data science, machine learning, and artificial intelligence capabilities across Amgens commercial organization.

Translating complex business, medical, or scientific questions into analytical frameworks and defining appropriate solutions, success measures, delivery plans, and business impact.

Identifying high-value business opportunities and independently recommending fit-for-purpose analytical, statistical, machine learning, or AI approaches.

Designing, building, validating, and deploying high-performance algorithms, predictive models, prototypes, and production-ready analytical solutions using Python, SQL, and PySpark, with a focus on performance, interpretability, scalability, and actionability.

Applying advanced measurement and experimentation approaches, including test/control design, causal inference, attribution, and other methods, to quantify business and promotional impact where appropriate.

Partnering cross-functionally with stakeholders to align on methodology, data requirements, assumptions, limitations, and interpretation of results.

Providing technical leadership and mentorship, contributing reusable methodologies and best practices, and staying current with developments in data science, machine learning, AI, and industry analytics.

Communicating complex analytical findings and recommendations clearly to technical, scientific, medical, commercial, and executive stakeholders through compelling storytelling and presentations.

Ensuring analytical solutions comply with applicable regulatory, security, privacy, data governance, and documentation requirements.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The collaborative and analytically driven professional we seek is a Senior Data Scientist with these qualifications.

**Basic Qualifications:**

- Doctorate degree OR
- Masters degree and 2 years of Data Science or related quantitative experience OR
- Bachelors degree and 4 years of Data Science or related quantitative experience OR
- Associates degree and 8 years of Data Science or related quantitative experience OR
  High school diploma / GED and 10 years of Data Science or related quantitative experience

**Preferred Qualifications:**

- Demonstrated experience independently leading end-to-end data science or advanced analytics projects and delivering measurable business value
- Strong programming skills in Python, SQL and PySpark
- Strong experience designing, evaluating, and applying supervised and unsupervised machine learning models, with familiarity with libraries and frameworks such as Pandas, scikit-learn, TensorFlow, NumPy, PyTorch, Spark, or equivalent tools
- Experience working with large, complex datasets and modern data platforms, including distributed computing, cloud environments, Databricks/Spark, and source control technologies such as Git
- Strong statistical, analytical, and problem-solving skills, with the ability to select appropriate methodologies and communicate assumptions and limitations
- Ability to manage multiple complex analytical workstreams, prioritize effectively, and operate independently in an ambiguous, fast-paced environment
- Demonstrated ability to collaborate with and influence cross-functional business and technical partners and drive analytical projects from problem definition through implementation and adoption
- Strong communication and storytelling skills, with the ability to translate complex technical analyses into clear, precise, and actionable recommendations for business stakeholders
- Experience with commercial measurement approaches such as experimentation, test/control design, causal inference, attribution, marketing effectiveness, or related impact measurement methods
- Preferred experience with transformer-based modeling and/or other advanced machine learning approaches; practical experience with AI/GenAI use cases or strong knowledge of emerging AI capabilities is highly valued
- Biotech/pharmaceutical or healthcare industry experience, including familiarity with healthcare data such as claims, patient, HCP, sales, or promotional data, is a plus

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now for a career that defies imagination**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Illinois

Senior Machine Learning Engineer

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Senior Machine Learning Engineer**

**What you will do**

Lets do this. Lets change the world. In this vital role, you will contribute to the development of scalable machine learning platforms and workflows that enable scientists and researchers across Amgen to build, deploy, and manage AI/ML models. You will work closely with experienced engineers, data scientists, and domain experts to productionize machine learning solutions primarily in support of drug discovery and development.

This is an ideal role for engineers early in their ML or software engineering careers who want to grow their expertise in MLOps, cloud platforms, and applied AI in life sciences. The ideal candidate has background in software engineering or computer science, has experience with commercial-grade, high reliability software and ML systems, and is passionate about the scientific and engineering aspects of designing new drugs.

This role is eligible for remote work within the US. While the role is remote, the interview process will include at least one in-person interview.

**Roles & Responsibilities:**

- Deliver AI and ML-enabled applications and platforms, with deployed models ranging from classical ML models to natural language processing, protein language models, and large language models.
- Contribute to the development and maintenance of ML platform capabilities, including:
  - Data pipelines and feature engineering workflows
  - Model training, evaluation, and deployment pipelines
  - Experiment tracking and model registry systems
  - Model performance evaluations and monitoring
- Partner in implementation of AI and ML Ops best practices, including CI/CD, cloud infra as code, monitoring, traceability and reproducibility.
- Collaborate with cross-functional teams to transition standards and outcomes from experimentation to production-grade enterprise solutions.
- Build and maintain scalable and efficient, productionized MLOps solutions on cloud platforms.
- Develop and deliver training content and knowledge articles to educate resident scientists on model lifecycle management best practices.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 2 years of relevant experience in Computer Science, IT, or related field

OR

Bachelors degree and 4 years of relevant experience in Computer Science, IT, or related field

OR

Associates degree and 8 years of relevant experience in Computer Science, IT, or related field

OR

High school diploma / GED and 10 years of relevant experience in Computer Science, IT, or related field

**Required Skills:**

- Software programming (Python, version control, test driven development).
- Experience with cloud technologies (AWS preferred, Databricks).
- Hands-on experience with AI/ML model training and serving.

**Preferred Qualifications:**

- Experience with deployment and maintenance of AI/ML models in production.
- Substantial experience with cloud technologies and platforms, such as Databricks, AWS (preferred), or Azure.
- Experience with AI and MLOps frameworks and tools (MLflow, Kubeflow, Weights & Biases, Terraform, etc.).
- Experience with containerization (Docker, Kubernetes).
- Familiarity with distributed data processing (e.g., Spark).
- Familiarity with data science libraries (scikit-learn, TensorFlow, PyTorch, LangChain).
- Experience with graph databases.

**Soft Skills:**

- Excellent critical-thinking and problem-solving skills.
- Strong communication and collaboration skills.
- Demonstrated presentation skills.
- Self-motivated, independent ownership and leadership skills.

**What you can expect from us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies

Apply now and make a lasting impact with the Amgen team.

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

AbbVie

Director, Global Program Manager - Oncology

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

1. Facilitates and drives cross-functional team effectiveness across the Asset Strategy Team by translating interconnected strategies into clear asset-level direction and execution within context of enterprise needs, disease area strategy, and therapeutic area objectives.
2. Proactively identify, communicate, and manage asset and disease level risks and subsequent mitigation plans. Ensure timely and accurate reporting within asset and/or disease area, including management of systems, and partnership with planning group in development of timelines.
3. Acts as the “COO” for the asset. Serves as the strategic thought partner to the ASL and Asset Strategy Team (AST) by synthesizing complex inputs across strategic cross-functional deliverables, and related strategies into aligned decisions and actions.
4. Serves as the strategic enabler of the Asset Team (AST), continuously driving value by optimizing team performance, streamlining cross-stakeholder communications, and developing compelling strategic narratives for governance forums.
5. Coaches and mentors Deliverable Team PM (DTPMs) and Project Planners to high performing project management expectations.

Responsibilities:

1. **Drive and contribute to Asset Team strategy and execution.** Serves as a core strategic partner to the Asset Strategy Team, coordinating activities and deliverables that translate interconnected strategies into executable plans. Bring critical thinking, business acumen, and enterprise perspective to cross-functional discussions, helping the team and the AST understand how their asset fits into the disease strategy bigger picture across the disease area. In partnership with the ASL and disease-area stakeholders, contribute to and influence cross-functional strategy across the portfolio.
2. **Ensure strategies are translated into** **integrated evidence plans across sub-teams and governance forums**, with clear accountability and follow-through.
3. Partner with Project Planners, and DTPMs and DST PMs to ensure **timely, accurate, and strategy-linked timelines, milestones, and reporting,**  including tracking progress against AST goals. Use scenario analysis and analytics to support **strategic decision-making, prioritization, and portfolio tradeoff discussions.**  Ensures dashboards, reports, and systems are timely and accurate.
4. **Proactively identify, communicate, and manage asset timelines and risks** with a stronger focus on strategic tradeoffs and early escalation. Partners with the **ASL** to identify and manage risks to the asset strategy, not only to individual deliverables. Apply judgment to assess implications of downstream changes to milestones, scenario plan, escalate critical issues appropriately, and ensure mitigation plans are in place for risks and transparent communication of cross-functional risks.
5. **Drive cross-functional Asset Strategy Team alignment and effectiveness.** Partners with the **ASL** to structure Asset Strategy Team discussions, improve decision-making, and ensure the team operates with focus, discipline, and efficiency. Coaches the team toward smaller, more focused strategy discussions and effective execution, ensuring the right SMEs are included in decision making discussions.
6. **Prepare the AST for rigorous, strategy-focused governance reviews.**  Plays a central role in readying the Asset Team for more rigorous TASC reviews and governance interactions by ensuring strategy is clearly articulated, supporting materials are well-structured, and key messages are aligned to the appropriate audience level. Develops the strategic storyboard for governance interactions.
7. **Strengthen execution excellence across the AST.**  Is the single “source of truth” across the asset for timelines, deliverables, budgets, and cross-functional connectivity across all DTPMs supporting the asset to ensure execution remains aligned to strategy and operating expectations. Ensures all reports, dashboards, and systems are timely and accurate.
8. **Build team capability and consistency in project management practices.**  Coaches and mentors DTPMs to elevate and deliver consistent PM practices and seamless workstreams, ensuring alignment in execution standards, communication, and issue management across sub-teams.
9. **Craft effective storylines and communications for stakeholders.**  Develops clear, strategic storylines that communicate the asset strategy, implications and downstream impacts of changes, and key decisions needed for governance and stakeholder engagement. Adjust messaging for different audiences to influence outcomes effectively.
10. **Share best practices and support continuous improvement.** Actively shares learning, benchmarks, and best practices with other GPMs, DTPMs, and Project Planners within the broader PM community to improve consistency, effectiveness, and strategic impact across supported assets.

Qualifications

Qualifications:

- Bachelor’s degree required, preferably in a relevant scientific, business, or technical field
- 4-6+ years of experience in a variety of roles and associated teams in the pharmaceutical/biotech industry (research & development, commercial, project management, operations) with a record of expertise in one or more therapeutic areas
- Minimum of 3 years supporting cross-functional teams in a core function (Program Management, Commercial, Development, Regulatory, Operations)
- Demonstrated growth in strategic thinking, leadership, and strategic communication, with the ability to articulate strategy and downstream impacts clearly and effectively across multiple assets, stakeholders, and audiences
- Strong written and verbal communication skills, with the ability to tailor messaging to different levels and functions within the organization
- Demonstrated knowledge of program management practices in the pharmaceutical industry
- Preferred: Experience in late-stage drug development, including participation on a launch team
- Experience with global teams in the pharmaceutical industry

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Data Scientist, Risk Based Quality Management Analytics

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Risk Based Quality Management (RBQM) Analytics is an ambitious team of Data Scientists and Data Engineers with a unique blend of Business, Scientific, and Machine Learning expertise that seeks to unleash the full potential of AbbVie’s data assets by bringing technology and/or data and insights to the forefront of decision making via fit-for-purpose solutions. The Data Scientist role is a key role to enable application of advanced analytics techniques across clinical development continuum. Drives Analytics innovation and experimentation to enable data-driven insights for complex business problems across R&D by deploying advanced analytics techniques like Machine Learning and Visual Analytics.

Responsibilities

- For assigned projects, works with the cross-functional team to enable fit-for-purpose analytics solutions.
- Works with team to ensure analytical work product is consistent across projects where appropriate and that user experience is optimized and follows the design principles and standards established by the team
- Leverages proven statistical methodologies and those methodologies established as standard by the team; in addition to leveraging proven statistical methodologies and standards established by the team, experiments and recommends additional techniques to solve business problems
- Enables data-driven insights to support of assigned projects
- If assigned, participates in functional innovation and process improvement initiatives;
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards.
- Identify business needs and support the creation of standard KPIs, reports, and statistical analyses

Qualifications

- Bachelor’s degree statistics, analytics, bioinformatics, data science or equivalent field. Master’s degree preferred
- Must have 2-3 years of Data science and analytics-related experience
- Complete or Full / Career proficiency in R, Python, SQL, or other statistical packages. Intermediate-level knowledge of statistical and data mining techniques
- Intermediate proficiency with visualization tools like Spotfire, Tableau, Microstrategy or equivalent
- Experience with Machine Learning and other advanced analytics techniques preferred
- Demonstrated effective communication skills. Demonstrated ability to communicate analytical and technical concepts in layman’s terms
- Demonstrated problem-solving and analytical skills
- Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolutediscretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Senior Principal Scientist, Precision Medicine Neuroscience

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Purpose:

Oversee the direction, planning, execution and interpretation of the Precision Medicine strategy associated with clinical trials or research activities of a clinical program. Participates as well as leads cross-functional teams to generate, deliver, and interpret high-quality clinical biomarker data supporting overall product scientific and business strategy.

Responsibilities:

- Manages design & implementation of the precision medicine strategy in support of the overall Product Development Plan, based on medical & scientific principles, knowledge of compliance & regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues.
- Lead cross-functional precision medicine teams to develop an overall precision medicine strategy that may extend to early translation of biomarker strategy from discovery to the clinic. Lead the development of a rigorous, cross-functionally-aligned, vetted precision medicine strategy in collaboration with matrix team members.
- Has responsibility for oversight of precision medicine strategy, monitoring overall timelines, budgets and interpretation, and communication of accumulating biomarker data to key stakeholders.
- Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial, Clinical Development and other functions in these activities as required, consistent with corporate policies.
- Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications

- Doctor of Philosophy (PhD) in science or related field with 10 years of related work experience (or equivalent with degree plus work experience).
- Ability to lead and develop a precision medicine strategy.
- Strong desire to collaborate in a cross-functional setting.
- Clinical trial experience in the pharmaceutical industry or academia.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols.
- Ability to interact externally and internally to support global scientific and business strategy.
- Must possess excellent oral and written English communication skills.
- Strong background in migraine/pain and/or obesity is preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Massachusetts

LBA Automation Scientist II

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The LBA Operations lab within Quantitative Translational & ADME Sciences (QTAS) in Worcester, MA, is seeking a motivated, independent, and experienced automation Scientist to support pre-clinical bioanalytical programs in a non-regulated and fast-paced environment. This role focuses on 1) the bioanalysis of animal samples dosed with large molecule therapeutics, including pharmacokinetic (PK), toxicokinetic (TK) pharmacodynamic (PD), and anti-drug-antibody (ADA) studies using manual and automated Meso Scale Discovery (MSD) assay protocols; and 2) designing and optimizing new automation protocols for the LBA workflow on Tecan and Hamilton liquid handlers.

The primary responsibilities of the Scientist I/II role include developing and executing bioanalytical strategies to support PK, PD, TK, and ADA studies via LBA using automated liquid handling systems. This lab-based role focuses on bioanalytical assay design, planning, data interpretation, and application of automation knowledge to increase analytical capabilities in support of oncology, immunology, and neuroscience portfolios.

The ideal candidate will have a strong background in bioanalysis, biochemistry, chemistry, or related fields along with bioanalytical assay automation. The candidate is expected to execute bioanalytical assay design and data interpretation, while driving automation strategies for pre-clinical sample analysis.

Duties & Responsibilities:

- Design and execute pre-clinical (rodent, NHP) bioanalytical studies using newly developed or existing bioanalytical protocols using manual and automated LBA protocols (Hamilton and Tecan instruments).
- Serve as an automation SME for the lab and set up automated assay strategies for large molecule bioanalysis.
- Effectively and clearly communicate assay plans, timelines, results, and data interpretations with study teams and QTAS stakeholders.
- Train and mentor junior scientists on LBA protocols using automation.
- Archive data in ELN and LIMS systems.
- Write and update experimental protocols and procedures.
- Initiate, design, interpret, and troubleshoot operational assays independently and efficiently.

Qualifications

- Bachelor’s degree in biochemistry, chemistry, or pharmacology with 7+ years industry experience or MS or equivalent with 5+ years of experience.
- Previous experience conducting PK/PD/TK bioanalysis on antibodies, bi/multi-specifics and/or ADCs, including data interpretation is required.
- Highly motivated, reliable, and independent contributor with attention to detail and problem-solving skills.
- Experience with assay development and troubleshooting using ligand binding workflows (ELISA, MSD) is a must. Automation experience is required.
- Team player. Excellent written and verbal communication skills.
- Proficiency with computers and data analysis software, including LIMS systems.
- Ability to design, summarize, communicate, and interpret bioanalytical results.
- Creative leader and problem solver who collaborates effectively in a highly matrixed environment.
  - This position is onsite and located at the AbbVie Bioresearch Center in Worcester, MA.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Senior Statistical Analyst - Programming - Oncology (Hybrid)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity. The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations.

**Responsibilities:**

Leads the statistical programming activities for projects with lower complexity.

- Leads the statistical programming activities for studies.
- Develop SAS programs for the creation of ADaM data sets following CDISC standards.
- Develop SAS programs for the creation of Tables, Listings and Figures.
- Validation of ADaM data sets, Tables, Listings and Figures.
- Create specifications for the structure of ADaM data sets for individual studies and integrated data.
- Create documentation for regulatory filings including reviewers guides and data definition documents
- Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
- Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.

Qualifications

**Minimum Qualifications:**

- Bachelors in Statistics, Computer Science or a related field
- 8+ years of relevant experience in quantitative analysis (or 6+ with a Masters)
- Experience with SAS Programming
- Experience leading programming for clinical trials

**Preferred Qualifications:**

- Masters Degree in Statistics, Computer Science or related field
- R Programming experience
- Oncology specific experience

**Other Required Skills:**

- Indepth understanding of SAS programming concepts and techniques related to drug development.
- Fundamental understanding of CDISC Standards.
- Fundamental understanding of the drug development process, including experience with regulatory filings.
- Ability to communicate clearly both oral and written.
- Ability to accurately estimate effort required for study related programming activities.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Clinical Research Associate

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.co.uk](<http://www.abbvie.co.uk/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

- Field-based CRA position
- Reporting to Clinical Operations Manager
- Excellent development opportunities, reward and benefits package

**Job Overview**

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials.

Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

**Responsibilities**

- Considered as the Primary Sponsor Point of contact for the investigative site. Experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening AbbVie's positioning
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activities
- Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects
- Understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy
- Able to connect the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey
  Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance."
- May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager
- Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance
- Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred or experience
- Independent clinical research monitoring experience of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
- Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders
- Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools and resources to provide customer centric support based on the health of the site
- Excellent interpersonal skills with strong written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
- Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information

AbbVie's UK offices in Maidenhead prioritize accessibility and employee well-being, creating a welcoming environment for everyone. The office includes a large car park for easy access, as well as step-free entry, accessible restrooms, and elevators to accommodate individuals with mobility challenges. The workspace features assistive technologies and adaptable workstations, fostering an inclusive culture. Additionally, there is a dedicated quiet zone for those who prefer to work without distraction. This area maximizes natural light and is strategically positioned for easy access with minimal noise disturbances. If you need specific information or have questions about accessibility arrangements, please let us know during the process.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)