Manufacturing & Production

Eli Lilly and Company

Associate - Health, Safety, and Environmental

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.

**Company Overview**

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

**Position Overview**

Lilly has built a state-of-the-art, highly automated campus in Concord, North Carolina, with warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need. If you ever wanted to have a direct impact on building a team’s culture and on how the team operates, now is the perfect opportunity!

The Health, Safety and Environmental associate collaborates with cross functional team members in operations, engineering, maintenance, quality, and HSE to develop, implement and continuously improve technical and cultural health and safety programs. This position will focus mainly on health and safety programs, although there may be some overlap into environmental systems.

**Key Objectives/Deliverables:**

- Engage site resources in achieving an interdependent safety culture.
- Partner with site HSE and cross functional teams to develop, establish, and sustain HSE systems, processes, and programs to ensure compliance with internal and external requirements and provide ongoing technical support.
- Understand and support HSE event investigations, CAPA and change control processes, and influence application of the hierarchy of controls to reduce risk, driving toward site and company goals to achieve an injury free workplace
- Provide floor support to multiple operations (this includes auditing, data collection, trending, and supporting local safety teams)
- Evaluate site equipment and processes against industry and internal standards to identify and prioritize improvements.
- Navigate complex systems and internal processes to accomplish tasks in an organized and efficient manner.
- Coach and train other HSE staff, leadership, and technical resources on both HSE technical aspects and culture development.

Basic Qualifications:

- Bachelor of science in scientific, engineering, or HSE-related discipline.

- Minimum 3 years’ experience in a full time health and safety role in a manufacturing environment.
- 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 Skills/Preferences:

- Experience in GMP manufacturing environments.
- Hands on, practical experience with common safe work practices, such as safe work permits, lock out tag out, working at heights.
- Practical experience evaluating and improving ergonomic employee concerns and injuries.
- Experience with incident investigation and root cause analysis
- Experience working with Veeva and Intellex platforms.

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

North Carolina

Associate Director – Technical Services/Manufacturing Science - Bioconjugate/Drug Product

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.

*Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.*

**Job Title:** Associate Director – Technical Services/Manufacturing Science (TS/MS / MSAT) - Bioconjugate/Drug Product Manufacturing

**Organization Overview:**

The TS/MS organization, also known externally as MSAT (Manufacturing Science and Technology) provides technical oversight to ensure robust and consistent biology and chemistry throughout all aspects of the manufacturing process. Through cross functional collaboration, TS/MS ensures the quality and safety of our products through process monitoring and knowledge to control, prevent and mitigate variability to deliver a reliable supply of medicine.

**Responsibilities**:

The Associate Director – TS/MS - Bioconjugate/Drug Product Manufacturing, will lead a technical organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions. TS/MS is responsible for ensuring manufacturing processes run reliably in state control through process monitoring supported through technical knowledge.

- Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence
- Lead, develop and retain a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement
- Provide coaching, mentorship and performance management to direct reports, ensuring individuals are developed to their full potential and the team is structured for long-term success
- Determine TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations
- Support the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant
- Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports
- Support the project team to deliver the facility to the site lead team ready to operate and on schedule

**Basic Requirements:**

- BS, MS, or PhD in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline, with 5+ years of experience in the biopharmaceutical industry
- Minimum of 3+ years in a people leadership role
- Experience in GMP manufacturing operations and supporting regulatory inspections and audits
- Experience in biological drug product manufacturing, with deep expertise in lyophilization process development and optimization

**Additional Skills/Preferences:**

- Advanced degree (MS or PhD) in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline preferred
- Knowledge of manufacturing processes, lab scale models, and unit operations used in the manufacturing of biotech products
- Knowledge of laboratory scale models and commercial scale biotech manufacturing processes
- Strong written and verbal communication skills
- Ability to work on own initiative and as part of a process team consisting of a diverse group of management, production/science, and engineering professionals
- Ability to respond quickly and proactively to changing priorities within a limited timeline

**Additional Information:**

- Travel is possible, but expected to be minimal
- Role is Monday through Friday onsite. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and / or off-hour work may be required.

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

$123,000 - $180,400

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

Virginia

Associate Director- Site Operations Procurement

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.

Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be part of the team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.

This position will initially support site readiness from a procurement perspective including the coordination of key procurement activities and the establishment of vendor/supplier relationships. The role will transition to be responsible for ongoing procurement activities once the site is operational.

Do you have high learning agility and experience partnering across diverse functions of business? This is an exciting opportunity to impact the future of Lilly manufacturing. Consider joining the Lilly family today!

**Key Objectives/Results:**

- Plan and execute the sourcing and purchasing of goods and services to support the site’s construction and later operations, following established policies and procedures (including negotiating with third-party suppliers, converting purchase requisitions into purchase orders, executing authority to commit and releasing orders to suppliers, and updating SAP data accordingly)
- Develop strong understanding of the site and ensure that the procurement strategy aligns with the site’s key operational, performance, and supply objectives. Communicate consistently with site leadership to ensure this alignment is maintained.
- Build and maintain strong relationships with Lilly’s Global Procurement organization as well as counterparts at other Lilly sites.
- Establish and cultivate relationships with local site suppliers (including negotiations) while integrating global suppliers into the site’s supply chain.
- Support Lilly’s supplier diversity initiatives.
- Establish, maintain, and update master supply agreements for which Lilly Richmond is a lead site or key influencer. Apply expertise and guidance from Global Procurement and align with global strategies.
- Lead all stages of supplier relations management activities for strategic third-party suppliers. Drive action items, resolve issues, and continuous improvement initiatives with suppliers.
- Negotiate with third-party suppliers, finalize agreements, and prepare contracts
- Seek out and implement quality, reliability, efficiency, and cost savings projects with suppliers. Consolidate and present gathered and forecasted site savings, in agreement with Global Procurement methodology.
- Make and/or support decisions regarding quality of materials/suppliers and settlement of material/supplier issues, while maintaining high-quality supplier relations.
- Conduct benchmarking analysis to evaluate market landscape for supported categories.
- Work with Global Procurement and Site Finance to establish strong arguments for the formation of new supplier relationships and for the establishment of new service lines with existing suppliers.
- Form and maintain close working relationships with demand planners and buyers as appropriate to ensure supply continuity, security, integrity while optimizing processes and minimizing waste, and accurate materials data (e.g., safety stock needs, pricing).
- Ensure compliance with Lilly procurement and financial policies and procedures, and regulatory commitments.

**Minimum Requirements**

- Bachelor’s degree in business, engineering, or similar field.
- 5 + years of experience in supply chain, manufacturing, and/or procurement related functions.
- 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**

- MBA
- Green or Black Belt training
- Experience working in a regulated environment
- Previous project management and vendor negotiation experience
- Ability to work autonomously, prioritize responsibilities, and be oriented toward action.
- Independent decision maker with ability to influence diverse organizations, both internally and externally.
- Strong teamwork, presentation, and relationship-building skills.
- Ability to adapt to continual change within a startup environment.

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

$127,500 - $187,000

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

Project Lead - SAP & Supply Chain Systems

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.

*Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.*

**Position Brand Description**

Lead implementation of new core applications (e.g. SAP Hana and EWM) and functionality at our Next Generation API Manufacturing Plant. Reporting to the Supply Chain function and playing a key role on the Materials Flow Team, the role leads the site in optimizing our use of SAP and logistics (yard management) technologies to enhance operational efficiency and effectiveness.

**Key Responsibilities:**

- Work closely with business process owners, data specialists and IT application owners (both local and global) to ensure the power of core applications is fully utilized for Material Management (SAP, EWN, yard management, RTLS, & other systems impacting material movements across the Richmond manufacturing site).
- SAP eWM Power user for Logistics Centre, interacting with IT Architects, MES architects, and Data Analytics architects.
- Support daily operations to ensure seamless interaction of core applications.
- Own the knowledge management and learning plan to ensure the user and super user capability at the site for SAP and other core applications meets business needs.
- Design, implement and govern incident escalation process for SAP applications.
- Monitor systems performance and recommend enhancements to optimize system functionality.
- Work with IT groups like Global Services and Global Infrastructure to support delivery of infrastructure for where required.
- Promote process improvement and innovation within digital applications to drive business process optimization.
- Adhere to corporate computer systems validation policies and procedures.
- Be an advocate for supply chain efficiencies through digital systems that streamline how materials flow across the Richmond manufacturing site.
- Progress the digital roadmap at the Richmond site helping development strategies for better integration across systems (MES & SAP).
- Work closely with Automation, IT and global teams to troubleshoot issues and ensure smooth integration of SAP applications with site business processes and other digital applications and hardware which are interfaced with SAP and yard management.

**Minimum Requirements:**

- Bachelor’s degree in Supply Chain, information systems, Computer Science, or related discipline
- Minimum of 5 years’ experience in manufacturing.
- Experience with integrated business process flows, driven by SAP applications, systems integration in a manufacturing facility.
- *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:**

- Experience in pharmaceutical manufacturing or other regulated industries.
- Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative and will run proactively with actions. Demonstrated self-management, prioritization, and organizational skills.
- Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions.
- Positive Influence: Demonstrated ability to address issues as they arise and act accordingly. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
- Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organization.
- Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
- Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.
- Decision Making: Demonstrated ability to be decisive and make well-informed decisions for the team's benefit. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.

**Additional Information:**

- Travel: 0-10%
- Onsite Position

\#LI\_MNLC

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

$132,000 - $193,600

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

Associate Director – Technical Services/Manufacturing Science - Analytical Support

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.

*Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.*

**Job Title:** Associate Director – Technical Services/Manufacturing Science (TS/MS / MSAT) - Analytical Support

**Organization Overview:**

The TS/MS organization, also known externally as MSAT (Manufacturing Science and Technology) provides technical oversight to ensure robust and consistent biology and chemistry throughout all aspects of the manufacturing process. Through cross functional collaboration, TS/MS ensures the quality and safety of our products through process monitoring and knowledge to control, prevent and mitigate variability to deliver a reliable supply of medicine.

**Responsibilities**:

The Associate Director – TS/MS - Analytical Support, will lead a technical organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions. TS/MS is responsible for ensuring manufacturing processes run reliably in a state control through process monitoring supported through technical knowledge.

- Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence
- Lead, develop and retain a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement
- Provide coaching, mentorship and performance management to direct reports, ensuring individuals are developed to their full potential, and the team is structured for long-term success
- Determine TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations
- Support the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant
- Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports
- Support the project team to deliver the facility to the site lead team ready to operate and on schedule

**Basic Requirements:**

- BS or higher in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline
- 10+ years of experience in analytical development, characterization, or technical support for biologics (mAbs/bioconjugates), including 5+ years in a people leadership role
- Experience in analytical method development for biologic drug substance and drug product
- Experience supporting or authoring CMC regulatory submissions

**Additional Skills/Preferences:**

- Advanced degree (MS or PhD) in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline preferred
- Experience in GMP manufacturing operations and supporting regulatory inspections and audits
- Knowledge of manufacturing processes, lab scale models, and unit operations used in the manufacturing of biotech products
- Knowledge of laboratory scale models and commercial scale biotech manufacturing processes
- Strong written and verbal communication skills
- Ability to work on own initiative and as part of a process team consisting of a diverse group of management, production/science and engineering professionals
- Ability to respond quickly and proactively to changing priorities within a limited timeline

**Additional Information:**

- Travel is possible, but expected to be minimal
- Role is Monday through Friday onsite. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and / or off-hour work may be required.

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

$123,000 - $180,400

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

Senior Safety Physician - CNS (remote)

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 and Position Overview**

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

We are seeking a **Senior** **Safety Physician** to join our Drug Safety/Pharmacovigilance team and provide medical safety leadership for **late-stage CNS clinical development program**. This is an opportunity to play a key role in safety evidence generation strategies, signal evaluation, risk management activities, benefit-risk assessment, and regulatory submissions through **NDA**.

As a Senior Safety Physician, you will play a key role in the oversight of safety data including medical review and assessment of individual case safety reports and aggregate reports, partnering closely with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Medical Affairs, and other cross-functional teams to ensure appropriate identification, assessment, characterization, and communication of emerging safety signals and risks. You will report to Associate Vice President of Pharmacovigilance and Safety.

**Responsibilities**

- Provide medical safety oversight for Phase 2/3 and other late-stage clinical studies.
- Review and interpret individual and aggregate safety data, including identification and evaluation of safety signals.
- Lead or contribute to safety surveillance, signal management, literature surveillance and benefit-risk assessments.
- Provide medical input into DSURs, PBRERs/PSURs, Risk Management Plans, Investigator's Brochures, and NDA submissions.
- Support regulatory interactions and responses to FDA and other health authorities globally.
- Partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs.
- Provide safety input into clinical protocols, safety monitoring plans, and development strategies.
- Support preparation for regulatory submissions, inspections, and audits.
- Communicate safety findings and recommendations effectively to cross-functional teams and senior leadership.
- Play an active role in building up the medical safety function at Centessa: conduct gap analysis, author and review SOPs, implement best practices and partner as needed with the broader Global Safety function at Eli Lilly.

**Basic Requirements:**

- MD, DO, or equivalent medical degree.
- 5+ years of pharmaceutical/biotech industry experience in Drug Safety/Pharmacovigilance or a closely related discipline.
- Demonstrated experience with late-stage clinical development and NDA submissions as well as post-marketing activities.
- Ability to drive drug safety evidence generation and risk mitigation strategies in a complex internal and external environment
- Expertise in safety signal evaluation, aggregate safety assessment, and benefit-risk evaluation.
- Sound knowledge and experience with FDA, EMEA/EU, ICH and other global pharmacovigilance and risk management regulations and guidelines.
- Strong clinical judgment, scientific communication, interpersonal and cross-functional collaboration skills.
- Ability to thrive in a fast-paced, entrepreneurial biotech environment.

**Additional Preferences:**

- Experience supporting a CNS program through late-stage development and NDA submission/approval, as well as experience with regulatory interactions and integrated safety analyses.
- Intrinsically curious and deeply passionate about the work we do.
- Embrace ambiguity and push for new practices and technologies.
- Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn’t clear.
- Leverage technical depth and a growth mindset to make impact; imagine what’s possible and pursue it with intention and energy.
- Demonstrate curiosity and drive self-identified innovation, especially in the exploration of artificial intelligence and digital.

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

$222,000 - $356,400

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

Advisor/Sr. Advisor - Technical Services/Manufacturing Science

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.

*Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.*

The Advisor/Sr. Advisor TS/MS, also known externally as MSAT (Manufacturing Science and Technology), will provide technical stewardship across the start-up advanced manufacturing facility. The successful candidate will be an expert in all aspects of bioconjugate manufacturing processes. This role will have accountability for up- and downstream processing and requires experience and deep knowledge of conjugation chemistry, purification and filtration processes, and the analytical and process controls specific to bioconjugate manufacturing.

The successful applicant will have experience with regulatory guidance and a familiarity with relevant strategies. They will have a strong skillset in data-driven decision-making and problem-solving capabilities, working continuously to drive process performance by implementing new technologies and process improvements. They will maximize the benefits of a digital plant to gain in-depth knowledge of the process through data analytics and process analytical technology. This role is for a cross-functional technical leader and is expected to set the standards for scientific curiosity and technical rigor for the site.

**Key Responsibilities:**

- Provide mentorship and scientific expertise to TS/MS bioprocess and laboratory scientists for process monitoring, trending, and analyzing production data. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations. Drive solutions to complex situations with impact across the site and functions.
- Understands, and performs all job responsibilities in compliance with safety and regulatory expectations and brings experience and knowledge of cGMP requirements to the role.
- Represent the site technically across the broader manufacturing network including other drug substance sites, drug product sites, global functions and process research and development. Reviews and approves annual product review and global product assessment.
- Partners with site leadership to ensure technical agendas are developed, implemented and managed compliant with all regulatory expectations and in alignment with business needs.
- Mentor scientists, engineers and operations staff and supports troubleshooting. Anticipates and resolves key technical or operational problems with impact across all functions. Communicates issues in a timely manner. May lead complex process-related investigations and assess technical impact.
- Closely partner with the quality assurance and quality control functions to provide technical oversight of the control strategy and ensure manufacturing process remain in a state of compliance.
- Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses and technical studies.
- Own or assist in the implementation of large process-related change controls with greater risk, resource and financial requirements or complexity.
- Supports development of strategy for regulatory submissions and the creation of related documentation.
- Excellence in technical writing and oral communication skills with the ability to effectively communicate and transfer knowledge to all levels of the organization.
- Works with scientists and engineers to ensure successful process knowledge transfer to the manufacturing staff on the production floor and assists in process-related training of manufacturing staff.
- Support the PAT and data science programs to ensure alignment between program execution, process scientists and control strategies.
- As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement medium to large continuous improvements to manufacturing processes.
- Works with Manufacturing to support the start-up and validation of the new facilities, process equipment and products during technology transfer. Helps to define, implement and own control strategies for new products.

**Attributes for the Role**

- Demonstrated technical acumen and high productivity
- Strong proclivity for technical leadership, teaching and mentoring
- Proven track record of curiosity and learning agility
- Self-starter with high initiative and data-driven approach to problem-solving
- Demonstrated strong interpersonal skills
- Demonstrated strong verbal and written communication skills
- Demonstrated adaptability and flexibility to working in fast pace, dynamic manufacturing environments
- Demonstrated ability to participate in and facilitate decision-making

**Basic Minimum Requirements:**

- MSc in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering or related discipline
- 5+yrs in ADC/mAb development
- Experience in commercial ADC/mAb mfg support
- Experience in inspection support

**Additional Preferences:**

- PHD in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering or related discipline
- 10+ years of experience within the biopharmaceutical industry

**Work Environment:**

- This role is 8-hours, day shift, and onsite. As a manufacturing support role, the need for occasional evening or weekend support can arise
- Occasional travel may be required

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

$129,000 - $209,000

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

Intellia Therapeutics

Director, Alternative Site of Care Strategy Lead

**Why Join Intellia?**

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

The **Director, Alternative Site of Care Strategy Lead** will play a key leadership role in advancing Intellia’s site-of-care capabilities. This role will help shape and execute approaches for engaging alternative sites of care and other infusion providers, with a focus on creating a high-quality, consistent experience for patients and providers.

This is a highly cross-functional role requiring strong strategic thinking, operational leadership, and stakeholder management. The Director will collaborate across Commercial, Medical, Market Access, Patient Services, Legal, Operations, IT, and other functions to assess opportunities, develop scalable capabilities and processes, and support effective execution of site-of-care initiatives.

**Duties/Responsibilities**

**Strategy & Channel Ownership**

- Serve as the single owner and strategic lead for the ASOC channel, defining the criteria, sequencing, and roadmap for which independent infusion providers to prioritize and onboard.

- Develop the business case, resourcing plan, and success metrics for ASOC integration, in partnership with the VP of Sales and Strategic Accounts leadership.

- Track and report progress against the operationalization plan, including timing, budget, and risk to the target go-live window.

**Provider Engagement & Contracting**

- Lead direct outreach, relationship-building, and negotiation with independent infusion providers to bring them into the Lonvo-z ATC network as ASOCs.

- Partner with Legal and Market Access to negotiate and finalize contracting terms with selected ASOC partners.

- Serve as the primary relationship owner for onboarded ASOC accounts post-contracting, ensuring a smooth transition into active network status.

**Cross-Functional Leadership & Coordination**

Act as the connective tissue across internal functions to ensure each workstream is executed on time and in an integrated fashion, including:

- **Field:**  Align with Sales Account Leads (SAL), Patient Access Leads (PAL), and Nurse Case Managers (NCM) to build the capacity and playbooks needed to support ASOCs alongside existing ATCs.

- **Marketing:**  Direct development of new ASOC-specific assets and adaptation of existing ATC materials for applicability to the ASOC channel.

- **Patient Services:**  Partner on Travel & Lodging modeling, Hub workflow integration, and development of forms/processes for the new ASOC patient pathway.

- **Medical:**  Support Medical Affairs on Lonvo-z clinical data discussions, protocol development, and HAE education/training relevant to ASOC providers (e.g., attack vs. anaphylaxis recognition, treatment response).

- **Market Access:**  Partner on GTN, ASP modeling, and FMV assessment specific to the ASOC channel.

- **Commercial Operations:**  Ensure ASOC accounts are built out in CRM system and properly incorporated into forecasting as a distinct source of business.

- **IT:**  Coordinate execution of data integrations (e.g., status reporting) into the CDE to support ASOC visibility and reporting.

**Governance & Reporting**

- Provide regular updates to the VP of Sales and relevant governance bodies on progress, budget, and risks.

- Support preparation of the full financial impact assessment and business case for formal approval.

**Requirements**

**Skills/Abilities**

- Bachelor's degree required; advanced degree (MBA, MHA, or related) preferred.

· 10+ years of experience in biotech/pharma commercial roles, with direct experience in specialty pharmacy, infusion services, site-of-care strategy, trade/distribution, or strategic account management.

· Demonstrated experience building or scaling a new channel, program, or network from the ground up, ideally involving external provider contracting/negotiation.

· Experience working directly with alternative sites of care or independent infusion providers required.

· Proven ability to lead complex, matrixed, cross-functional initiatives without direct authority over contributing teams.

· Experience in rare disease and/or launch-stage commercial environments preferred; familiarity with hereditary angioedema (HAE) or gene-editing therapies a plus.

· Strong contracting/negotiation acumen; comfort partnering closely with Legal and Market Access on deal terms.

· Excellent executive communication skills; able to synthesize complex, multi-workstream status into clear updates for senior leadership.

· Willingness to travel extensively (estimated 40–60%) to engage independent infusion providers nationally.

Bachelor's degree required; advanced degree (MBA, MHA, or related) preferred.

·

\#LI-KO1 remote

**_EEOC Statement:_**  *Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.*

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $225,000.00 - $275,000.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please [click here](<https://www.intelliatx.com/careers/join-us/>).

Massachusetts

Civica Rx

Manufacturing Support Lead (620)

Job Description:

The Manufacturing Support Lead supports daily manufacturing operations and serves as the frontline technical and operational leader within the Manufacturing Support department. This role provides day-to-day guidance, training, coordination, and technical expertise to manufacturing associates while supporting equipment qualifications, process improvements, documentation ownership, and compliant pharmaceutical manufacturing operations. The Manufacturing Lead promotes safe, efficient, and compliant production while fostering collaboration, continuous improvement, and adherence to the Civica mission of serving patients.

Essential Duties and Responsibilities:

• Provide daily direction, coordination, and support to Manufacturing Associates during routine operations.

• Act as a subject matter expert for manufacturing support processes including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).

• Support equipment qualification, commissioning, validation, and start-up activities.

• Serve as the primary point of contact for operational issues and escalate concerns to supervision when necessary.

• Assist with maintaining inspection readiness and support regulatory inspections and audits.

• Ensure personnel are trained and qualified prior to performing assigned activities.

• Support development, revision, and implementation of SOPs, batch records, and governing documents.

• Promote compliance with FDA, cGMP, ISO, safety, and company requirements.

• Identify and implement process improvements using Lean Manufacturing principles.

• Assist with investigations, root cause analysis, deviations, CAPAs, and change controls.

• Mentor and train associates on technical processes, documentation practices, and operational excellence.

• Coordinate activities across shifts and departments to ensure operational continuity and effective communication.

• Maintain accurate production and compliance documentation.

• Provide operational feedback to leadership regarding staffing, training, and process improvement opportunities.

• Maintain flexibility to support production schedules and business needs.

• Ability to work on-site is required.

Basic Qualifications and Capabilities:

• High school diploma or equivalent with 3+ years of Operations or Manufacturing Support experience in Pharmaceuticals (cGMP, FDA-regulated, ISO, or similar manufacturing environment).

• Experience with autoclaves, parts washers, and manufacturing support equipment.

• Previous experience serving as a team lead, trainer, or informal leader in a GMP manufacturing environment preferred.

• Knowledge of process improvement, change management, and manufacturing investigations.

• Lean Manufacturing and/or Six Sigma experience preferred.

• Strong documentation, communication, and interpersonal skills.

• Self-directed with strong problem-solving and analytical abilities.

• Ability to collaborate effectively across departments and shifts.

Physical Demands and Work Environment:

The physical demands described here are representative of those required to perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use their hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate. The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

Manufacturing Technician Lead - Vial Line - 1st Shift (296)

Position Summary:

Manufacturing Technician Lead – Vial line will be responsible for providing leadership within the area’s team, owning initiatives, acting as a liaison between operations and functional groups to support event management, change controls, etc. The Manufacturing Lead Technician will also assist the operations team in the day-to-day oversight of the production floor and lead investigations and drive implementation of actions associated with deviations

Essential Duties and Responsibilities:

• Support Site Leadership to build a capable site organization by delivering area operational procedures, quality processes, and controls for the manufacturing areas.

• Monitor and build a strong safety culture.

• Actively leads manufacturing floor operations and drives timelines.

• Fully trained in the escalation process for delays or issues that may arise.

• Participates and/or leads cross-functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root

Cause Analysis (RCA), Failure Modes and Effects Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE)

• Lead training and troubleshooting for operations.

• Assist in OJT tracking to ensure users are up to date on training and qualified to perform operations.

• Work closely with Logistics on the release of orders.

• Work closely with QA on the floor for comment resolution, deviation initiation, troubleshooting, and timelines.

• Understand and influence the manufacturing control strategy for their area.

• Trained as a Deviation Investigator.

• Development and monitoring of metrics for the area.

• Aid in issue resolution, batch/product approvals, and production schedule execution.

• Lead specific activities of the process teams.

• Any other activities as designated by management.

Basic Qualifications and Capabilities:

• High School Diploma or equivalent.

• Experience: 4+ years of Operations or Manufacturing Support in Pharmaceuticals.

Physical Demands and Work Environment:

• Standing and Walking: Ability to stand and walk for extended periods (up to 8–12 hours per shift).

• Manual Dexterity: Frequent use of hands and fingers for handling, operating equipment, and performing precise tasks.

• Lifting and Carrying: Ability to lift, push, or pull up to 50 lbs occasionally and up to 25 lbs frequently.

• Repetitive Motions: Regular bending, stooping, reaching, and twisting during production activities.

• Visual Requirements: Good visual acuity for reading labels, monitoring equipment, and performing inspections.

• Auditory Requirements: Ability to hear alarms, equipment sounds, and verbal instructions in a low-to-moderate noise environment.

• Personal Protective Equipment (PPE): Must wear appropriate PPE (gowning, gloves, safety glasses, masks, etc.) for extended periods.

• Shift Work: May require weekends and overtime based on production schedules.

• Controlled Environment: Work performed in cleanroom or controlled manufacturing areas following strict GMP guidelines.

• Safety Compliance: Strict adherence to safety protocols, gowning procedures, and contamination control measures

Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. The company is an equal opportunity employer, a drug-free workplace, and complies with applicable ADA regulations

Manufacturing Manager - Vial Line 1st Shift

**Job Description**

The Manager, Manufacturing, Vial Fill, will play a role in the facility start-up, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site. The Manager will develop and support the Manufacturing team by participating in equipment qualification, identifying and implementing process improvements through process monitoring, and conducting investigations and impact assessments. Lead the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of quality injectable products according to the Civica culture and vision of what is in the best interest of the patient.

**Essential Duties and Responsibilities:**

· Under the Director of Manufacturing’s direction, actively participate in new equipment and process qualifications.

· Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements.

· Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.

· Responsible for identifying opportunities to improve customer service, quality, safety, performance, scrap minimization, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing.

· Mentors, coaches, and teaches Manufacturing Associates in the use of statistical tools, Lean/Six Sigma methodologies, and change management/control techniques to ensure timely completion of projects with the expected results.

· Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing.

· Identifies corrective and preventive actions (CAPA) and leads projects to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis.

· Demonstrated ability to act as subject matter expert in manufacturing equipment build and function, as well as in manufacturing processes, including aseptic filling, isolator/RABs technology, and packaging.

· Flex schedule to meet commitments and achieve milestones related to projects, production, and other demands of the role.

**Minimum Qualifications (Knowledge, Skills, and Abilities)**

· Bachelor's degree with 8+ years of demonstrated ability in a cGMP FDA, cGMP, ISO, or other regulated production environments. Equivalent education and experience may be considered.

· Advanced experience in a process improvement environment, including project management, change management, and leading Lean/Six Sigma project teams. Certification is a plus.

· Prior high-speed fill/finish (vial, cartridge, PFS, etc.) experience required.

· Expert facilitation skills with demonstrated results.

· Interact with other functions and must be able to take ownership of and follow through on assigned projects.

· Demonstrated excellence in oral and written communication.

· Self-directed with effective analytical and problem-solving skills.

**Physical Demands and Work Environment:**

The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. Must be able to gown in accordance with site procedures and work in controlled manufacturing environments. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable.

Jazz Pharmaceuticals, Inc.

Associate Director, DEC Supply Chain Capability Lead (Remote/Home Based)

**If you are a current Jazz employee please apply via the Internal Career site.**

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit [www.jazzpharmaceuticals.com](<https://www.jazzpharmaceuticals.com>) for more information.

**Brief Description:**

Jazz Pharmaceuticals is seeking an Associate Director, DEC Supply Chain Capability Lead to support digital product strategy and act as a strategic technology partner and trusted advisor to Global Supply Chain.

The Associate Director, DEC Supply Chain Capability Lead is a technology and business leader responsible for strategy, delivery, and operational excellence of platforms and products supporting Global Supply Chain. This role operates with a product operating model mindset, supporting a portfolio of platforms and products to ensure they are secure, scalable, and continuously optimized to deliver measurable business outcomes including business process improvement, operational efficiencies, and innovation.

The role provides cross-functional domain leadership and technical ownership for digital platforms and capabilities supporting Technical Operations platforms and adjacent data and workflow platforms, spanning process enablement, integrations, data integrity, security, and operational resilience.

As a trusted partner to Global Supply Chain leaders, this role supports technology priorities and investment tradeoffs, aligning product development with business strategy, regulatory obligations, and value realization goals.

**Essential Functions/Responsibilities**

**Drive Cross-Channel Digital Excellence**

- Support the DEC strategy across Global Supply Chain by translating business priorities into clear plans, roadmaps, and measurable outcomes.
- Partner with business and technology stakeholders to prioritize enhancements, manage tradeoffs, and deliver platform improvements that meet functional needs.
- Help mature the product operating model by establishing practical ways of working, governance, and prioritization for Supply Chain platforms.
- Oversee the day-to-day health and evolution of platforms supporting Supply Chain.

**Risk & Controls (GxP)**

- Ensure platforms supporting Supply Chain operate in line with GxP and other regulated requirements, including support for validation, audit readiness, and issue remediation.
- Partner with internal teams to maintain strong controls related to security, data integrity, access, and change management.
- Monitor risks, escalate issues as needed, and support actions that improve platform stability, resilience, and compliance.

**Leadership & Operating Model**

- Lead and develop a high-performing team of capability leaders responsible for digital products supporting Global Supply Chain operations, delivery, and continuous improvement.
- Manage vendor and partner relationships to support digital product delivery, service quality, and business priorities.
- Collaborate with architecture, delivery, and business teams to align solutions with enterprise standards and functional needs.
- Support planning for product capacity, lifecycle management, upgrades, and service improvements.

**Integration & Data & AI Enablement**

- Support integration planning across Technical Operations products to enable reliable data flow and business processes.
- Work with technical teams, the Data & AI Product Tech Lead and the enterprise data capability owners to apply consistent integration and data standards across Global Supply Chain platforms.
- Partner with Data & AI Product Tech Lead and enterprise analytics and AI leaders to enable AI and analytics features within products and to integrate data & AI products into capability roadmaps.

**Required Knowledge, Skills, and Abilities**

- 8-10 years of progressive leadership in delivering or managing Technical Operations related systems and products, Pharma experience required.
- Demonstrated ownership of Technical Operations solutions supporting research and nonclinical development or related domains, along with adjacent reporting and integration platforms.
- Proven accountability and ownership in GxP-regulated environments, including audit management, validation support, and governance of regulated operations.
- Experience with enterprise ownership of digital platforms supporting Technical Operations and regulated operations.
- Strong enterprise mindset with the ability to balance functional needs with product delivery standardization and long-term value.
- Product-oriented leader with experience delivering measurable, value-based outcomes rather than project outputs.
- Trusted advisor to business leaders, with strong communication and stakeholder-management skills.
- Experience in leading and developing high-performing teams.

**Required/Preferred Education and Licenses**

- Bachelor’s degree in a related science, technology or Information Systems field

*Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.*

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: [https://careers.jazzpharma.com/benefits.html](<https://careers.jazzpharma.com/benefits.html>).

Other Non-US

Immunocore

Director Safety Physician, Global Safety Lead

Vacancy Name

Director Safety Physician, Global Safety Lead

Vacancy No

VN891

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA, Oxford, UK

Department

Regulatory Affairs

Key Responsibilities

The Director Safety Physician, Global Patient Safety, is a physician with a robust medical and scientific expertise in clinical medicine, clinical safety evaluation, and pharmacovigilance. The role-holder leads proactive and timely benefit-risk assessments, drives advanced signal detection and analyses from diverse data sources (clinical trials, post-marketing surveillance, real-world data), and shapes the evolving safety profiles of Immunocore’s innovative development and marketed products. The Director Safety Physician is responsible for the successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations. This Director Safety Physician provides guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and post-marketing surveillance. This role provides a unique opportunity to collaborate closely with cross-functional colleagues such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.

KEY RESPONSIBILITIES

• Drive the strategic vision and execution of safety surveillance and benefit–risk assessment across the life cycle of assigned products, including the development and refinement of project-level safety evaluation and reporting strategies.

• Ensure alignment with clinical and regulatory objectives, gain cross-functional agreement, and adapt strategies based on evolving insights from single cases and aggregate data.

• Anticipate and shape emerging safety issues by creating strategic benefit–risk frameworks that inform labelling, clinical trial design, and post-marketing commitments.

• Ensure consistency in approaches to emerging safety findings from clinical studies, gain cross-functional alignment, oversee implementation, and adapt strategies based on evolving insights from individual cases and aggregate data.

• Provide medical and scientific leadership in signal detection, analysis, and input into governance forums, setting cross-functional safety strategy and providing recommendations that impact corporate decision-making.

• Provide cross-functional leadership to ensure consistency in safety data collection and reporting for the assigned products.

• Provide medical review of case safety reports (ICSRs), including causality, seriousness, expectedness, and clinical relevance, ensuring medical accuracy and regulatory compliance.

• Ensure accuracy and timeliness of expedited reports and periodic reports from clinical trials and post-marketing surveillance.

• Participates in the identification, analysis and reporting of possible trends and concerns with company products including the identification and evaluation of safety signals through assessment of single case safety reports, aggregate trend analyses, and literature review.

• Responsible for signal detection and evaluation, conducting scientific analyses of clinical trial, post-marketing, literature, and epidemiological data to support timely risk identification and mitigation.

• Lead the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues.

• Accountable for the preparation and maintenance of Reference Safety Information (RSI) and product labelling (e.g., Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels), Risk Management Plans (RMP).

• Accountable for medical and scientific input into responses to regulatory authority queries regarding product safety and risk management.

• Guide internal collaborators and external vendors in best practices for safety data collection, coding, analyses and evaluation, ensuring high-quality standards.

• Oversee the preparation and review of safety sections of regulatory submissions, including DSURs, PBRERs, Risk Management Plans (RMPs), Investigator Brochures, and labelling updates.

• Accountable for the medical and scientific accuracy and quality of aggregate safety reports (DSUR, PBRER), risk management plan(s), and safety sections of health authority queries, protocols, and investigator brochures

• Author medical-safety sections of submission documents (Summary of clinical Safety, Clinical Overview).

• Maintain up-to-date knowledge of Immunocore therapeutic areas and global regulatory requirements for PV.

• Participate in development of internal PV business infrastructure including standard operating procedures and work practice instructions to ensure seamless PV processes.

SUPERVISORY RESPONSIBILITY

This position will not have line manager responsibilities, but provides safety leadership to cross functional teams

COMPETENCIES

• Strong medical and clinical judgment in evaluating adverse event data and benefit–risk profiles.

• Strong scientific and analytical skills, with the ability to translate data into meaningful insights.

• Collaborative leadership in cross-functional activities.

• Effectively communicate/present complex scientific and medical concepts to both medical and non-medical audiences.

• Knowledge of global PV regulations and risk management requirements (FDA, EMA, ICH, CIOMS).

EXPERIENCE & KNOWLEDGE

Essential

• Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies.

• Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission.

• Knowledge of clinical development process

• Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.

Desirable

• Advanced degree in epidemiology, pharmacology, or biomedical sciences (PhD/MPH)

• Knowledge of drug approval process in major countries

• Experience with different commercially available safety databases.

• Board certification in a relevant specialty

• Experience in regulatory submissions and interactions regarding drug safety

EDUCATION & QUALIFICATIONS

• M.D./D.O. degree with at least three years of pharmacovigilance experience, and at least two years of clinical experience or relevant experience to understand clinical drug development

• At least three years of practical clinical experience post licensure

US Market Data

$205,000-$260,000

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Maryland

Beeline Medicines

Senior Executive Assistant & Office Operations

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Senior Executive Assistant & Office Operations is a highly trusted, senior-level partner responsible for providing exceptional executive support to senior leaders and members of the Research & Development organization while also partnering on key office operations for the Boston location. This role supports a globally distributed leadership team and partners closely with the Senior Executive Assistant to the Chief Medical Officer (CMO) and the Research & Development Leadership Team (RDLT) to coordinate high-priority activities, leadership meetings, and strategic initiatives.

In addition to executive support, this role serves as the primary owner of office operations and facilities management for the Boston location, partnering closely with the Director, Corporate & Administrative Services on workplace planning, construction, branding initiatives, and employee experience. This position is part of Beeline Medicines’ broader Executive Assistant team and is expected to flex in supporting firmwide priorities and events.

The ideal candidate is a polished, poised, and highly resourceful professional who excels in fast-paced biotechnology environments. They demonstrate exceptional judgment, executive presence, discretion, and the ability to quickly assess competing priorities. Success in this role requires someone who can rapidly learn organizational dynamics, understand the relative importance and urgency of meeting requests, and confidently manage complex scheduling challenges while maintaining a high level of professionalism

**Work Arrangement & Location:**

**Hybrid -** This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as **Tuesday and Wednesday**. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

**Essential Duties and Responsibilities:**

- Provides dedicated support to the assigned executives and works closely with assigned functional departments across the organization
- Provide proactive, high-level executive support, managing complex calendars, travel, expenses, and rapidly evolving priorities.
- Partner closely with the Senior Executive Assistant to the CMO and the RDLT to coordinate leadership meetings, strategic planning sessions, governance forums, and other high-priority engagements.
- Exercise sound judgment in prioritizing meeting requests and managing competing executive demands, ensuring leadership time is aligned with organizational priorities.
- Manage complex calendaring across multiple global time zones and facilitate coordination among internal and external stakeholders.
- Plan and coordinate domestic and international travel, including multi-stop itineraries, executive briefings, and contingency planning.
- Support executive interactions with key external stakeholders, advisors, investigators, and partners, including scheduling, logistics, preparation, and follow-up.
- Serve as a trusted partner who anticipates needs, identifies potential conflicts, and proactively recommends solutions.
- Coordinate office and pantry supplies, maintaining appropriate inventory levels and employee amenities in partnership with the Senior Executive Assistant.
- Review office and facilities-related expenses and identify opportunities for operational efficiencies and cost optimization.
- Partner on facilities matters, including maintenance requests, vendor relationships, building management coordination, and work orders.
- Serve as an engaged and collaborative member of the Executive Assistant team, supporting company-wide initiatives and shared priorities.
- Support logistics and planning for town halls, leadership meetings, all-hands meetings, company events, employee engagement activities, company-wide mailings, and cross-functional initiatives.
- Demonstrate flexibility and willingness to support evolving business needs and organizational priorities.
- Perform other duties and responsibilities as assigned

**Qualifications:**

- Education: Bachelor's degree or equivalent professional experience required.
- Minimum of 15 years of experience supporting Csuite executives and senior leadership teams in fast paced, global environments.
- Prior experience in biotechnology or life sciences strongly preferred; R&D or clinical development experience is a plus.
- Proven ability to support multiple senior leaders simultaneously with discretion, professionalism, and confidence.
- Extensive experience working across global time zones and supporting internationally based executives.
- Experience supporting industry congresses, scientific meetings, and senior level external engagements.
- Advanced proficiency in Microsoft Office suite, including Outlook, Word, Excel, and PowerPoint.
- Experience with DocuSign, SharePoint, Coupa, SAP, and Concur or comparable expense management platforms.
- Strong command of video conferencing and collaboration tools.
- Comfortable adopting new technologies; familiarity with AI-enabled productivity tools such as Microsoft Copilot is a plus
- Operates with a high degree of autonomy and ownership, functioning as a trusted extension of executive leadership in both internal and external settings.
- Anticipates organizational needs before they surface, proactively identifying risks, gaps, and opportunities to keep executive priorities on track.
- Self-directed and confident, with the ability to orient quickly in ambiguous or fast-moving environments.
- Communicates with clarity, precision, and discretion across all levels of the organization, tailoring style and tone to audience and context.
- Navigates sensitive information with professionalism and strict confidentiality, exercising discretion in all written and verbal interactions.
- Highly effective interpersonally; able to build trusted relationships with executives, cross-functional teams, vendors, and external partners.

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$113,000 - $146,000 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Novo Nordisk

Technician III Engineering Process

**About the Department**

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including **14 paid holidays**
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

A Technician III, Engineering Process's primary duty is to provide direct technical support to operations area as it relates to equipment. This role will work collaboratively with multiple functions and departments to ensure equipment and associated production systems operate in a safe, and quality-oriented manner. Responsibilities include: providing training and assessment support for equipment operation, set-up, changeover, and troubleshooting, providing recommendations and implementing solutions to resolve equipment and/or process problems in a timely manner, creating and revising GMP as it relates to equipment activities, supporting or owning work orders and preventative maintenance.

Note: This role works 6PM - 6:30AM on a 2/2/3 rotating schedule (Shift B)

**Relationships**

Reports to Manager.

**Essential Functions**

- Complete work under supervision by more experienced team members with increasing independence as experience, training, and job specific aptitude are gained
- Use judgment within generally defined guidelines to identify solutions to problems
- Interact with other departments to schedule activities around the production schedules of the cGMP Manufacturing and Process Development departments. Schedule self-performed work assigned at beginning of month and due by end of month
- Follow general instructions on routine work and detailed instructions of new work
- May design new approaches to problems encountered and use a wide application of complex principles, theories, and concepts in the specific field
- Use hand tools, power tools, and delicate testing equipment in performance of duties
- Complete non-routine repair work orders for regulated and unregulated systems
- Effectively document work performed following required documentation practices
- Be available and respond to site as part of the on-call rotation (optional for Calibration)
- Escort and supervise contractors through facility for routine inspections or repairs, ensuring they complete activities per procedure or agreements
- Perform basic troubleshooting as it related to assigned job duties
- Work with shipping to send out equipment or standard for offsite vendor service and track status
- Contribute to the creation of maintenance and calibration procedures and update existing procedures to match best practices and lessons learned
- Identify and order spare or replacement parts for equipment utilizing inventory management system
- Recommend facility improvements to meet OSHA safety, ISPE, or FDA guidelines
- Opportunity to contribute on Safety Committee, Environmental Engagement Committee, or other corporate responsibility areas
- Assist with onboarding new equipment and retiring obsolete equipment
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 25 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled.

**Qualifications**

- High school diploma with at least 5 years of relevant experience
- Associate degree in maintenance related field, preferred
- Education/Experience:
  - Possesses advanced electrical and mechanical skills and education
  - Highly skilled and/or certified in at least one trade
  - Must be able to read and understand English-written job instructions and safety requirements
- Technical Requirements:
  - Ability to see and hear, read, and write clear English
  - Mechanical and electrical aptitude
  - Ability to gown for entry in clean room environment
  - Ability to operate within a clean room environment
  - General facility repair, maintenance, and up-keep
  - Ability to understand basic training and apply the knowledge to work activities
  - Ability to apply basic math
  - Ability to use Excel, Word, and other office systems
  - Ability to review data to ensure data is well organized with complete documentation
  - Ability to problem solve and execute/monitor corrective action independently
  - Ability to cross-train on techniques across multiple groups
- Behavioural Requirements:
  - Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner
  - Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
  - Ability to cooperate with coworkers within an organized team environment or work alone

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

AbbVie

Senior Auditor, Supplier Audit & Compliance

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**:

Primarily responsible for carrying out comprehensive quality system audits of third-party service providers and manufacturers for compliance with applicable global regulatory requirements. Responsible for providing quality

consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide

**Responsibilities**:

- Carry out job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies.
- Independently plan and conduct external supplier audits assessing compliance of systems, facilities, and processes per applicable regulations and AbbVie specifications.
- Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained.
- Assist in maintaining approved supplier list, global audit schedule and participate in supplier management processes (e.g. Management Review, Supplier Change Notifications, etc.).
- Provide guidance and training on GxP regulations and guidelines to audit team members and internal business partners.
- Assist on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers.
- Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
- Expected to elevate any issues to management, as necessary, in meeting these responsibilities.
- Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight.
- Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
- Collaborate with AbbVie Operations in coordinating and conduct of joint audits.
- Ensures audits are conducted according to the annual audit schedule.

This is an experienced level compliance position that reports to the Director RDQA External Partners Quality Audit or designee. This individual is expected to identify and resolve problems through effective interpersonal skills. The incumbent will work effectively independently or as a team, mentor others, and also be an effective cross-functional team leader. Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas.

Qualifications

- Bachelor’s degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).
- Demonstrated strong leadership competencies, proficient level of technical capabilities, and

independence. Proven track record utilizing core & technical competencies.

- 8+ years’ total experience, including 3+ years in compliance or auditing role.
- Sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries and thorough understanding of international GMP and Device regulatory standards (e.g. US FDA, EU, MDR/IVDR, etc.).
- Quality Assurance auditing experience (preferred)
- Pharmaceutical/Device Manufacturing experience (preferred)
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ)
- Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA))

Additional Information

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>)

Internship- EHS Engineer

**About the Department**

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Program**

At Novo Nordisk, interns will have the opportunity to work closely with experienced industry professionals and gain valuable, hands-on, full-time work experience. For ten weeks, interns will be immersed in the environment of a global pharmaceutical company and contribute to the line of business by providing sustainable and meaningful project work. Our internship program also includes instructor-led trainings, a leadership engagement series, as well as insightful lunch and learns.

Program Start: May 17, 2027

Program End: July 23, 2027

**Scope of Position**

The Environmental Health and Safety (EHS) Engineer Intern will support site environmental, health, and safety initiatives to strengthen operations and ensure regulatory compliance.

Responsibilities include collecting and analyzing EHS data, assisting with the update and maintenance of procedural documentation, supporting EHS training programs, and contributing to process improvement efforts. The intern will also help advance sustainability initiatives and support adherence to applicable environmental and safety regulations across the site.

In addition, where applicable, the intern will support Process Safety Management (PSM) activities by applying engineering technical skills to develop process maps and draft technical summaries. The intern will participate in process hazard analysis efforts and contribute to enhancing chemical safety across the site.

**Physical Requirements**

- 0% overnight travel required.

**Qualifications**

- Pursuing an undergraduate or graduate degree.
- Engineering, Environmental Science, and/or Occupational Safety majors preferred.
- Must be a rising junior, or rising senior with a 3.0 GPA or above.
- Excellent computer skills to include Proficiency in Excel, Word & familiarity/capability in most other Microsoft Office applications.

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

**About the Department**

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Program**

At Novo Nordisk, interns will have the opportunity to work closely with experienced industry professionals and gain valuable, hands-on, full-time work experience. For ten weeks, interns will be immersed in the environment of a global pharmaceutical company and contribute to the line of business by providing sustainable and meaningful project work. Our internship program also includes instructor-led trainings, a leadership engagement series, as well as insightful lunch and learns.

Program Start: May 17, 2027

Program End: July 23, 2027

**Scope of Position**

The Environmental Health and Safety (EHS) Engineer Intern will support site environmental, health, and safety initiatives to strengthen operations and ensure regulatory compliance.

Responsibilities include collecting and analyzing EHS data, assisting with the update and maintenance of procedural documentation, supporting EHS training programs, and contributing to process improvement efforts. The intern will also help advance sustainability initiatives and support adherence to applicable environmental and safety regulations across the site.

In addition, where applicable, the intern will support Process Safety Management (PSM) activities by applying engineering technical skills to develop process maps and draft technical summaries. The intern will participate in process hazard analysis efforts and contribute to enhancing chemical safety across the site.

**Physical Requirements**

- 0% overnight travel required.

**Qualifications**

- Pursuing an undergraduate or graduate degree.
- Engineering, Environmental Science, and/or Occupational Safety majors preferred.
- Must be a rising junior, or rising senior with a 3.0 GPA or above.
- Excellent computer skills to include: Proficiency in Excel, Word & familiarity/capability in most other Microsoft Office applications

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Technician, Pilot Plant IV (3rd Shift)

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

Set-up, clean, and maintain equipment. Run process with supervision and consults appropriate personnel when confronted with a problem or when made aware of a situation. Observes quality characteristics of products and processes. Complete documentation per current good manufacturing practice guidelines and policies.

**3rd Shift:** Sun - Thurs, 11pm - 7:30 am

**Responsibilities**

- Learn and follow department policies, procedures and guidelines. Complete documentation and supporting data per cGMP policies, procedures, and guidelines.
- Maintain a safe and clean work environment.
- Develop systematic work habits that show effective organizational skills.
- Be able to prepare for process requirements following supervisory instruction.
- Note quality issues and address with appropriate people.
- Review procedures and batch records, and make suggestions for improvements. During pre runs, post runs and when reviewing direction sets identify safety issues and help to correct them.
- Consistently give an accurate and complete material and equipment status report when handing off manufacturing process.
- Learn and be able to use inventory system.

Qualifications

- High School diploma or GED equivalent required. Bachelors or Associates Degree in a scientific related field is desirable.
- Job requires basic technical or mechanical background and knowledge.
- Must have ability to:
  1. Read, understand, and follow verbal and written operating instructions and the processes and flows described on equipment/computer monitors;
  2. Write at a level sufficient enough to explain deviations or mistakes in process;
  3. Add, subtract, divide, multiply, use decimals and fractions, recognize and measure proportions, and do basic algebraic math at an intermediate level of competency.
- Knowledge and use of various tools, machines, instruments, and safety devices utilized in chemical or pharmaceutical operations is desired. The candidate should display mechanical aptitude and be able to follow written and verbal directions.

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>)

Illinois

Global Occupational Health Program Manager

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: This position is accountable for furthering the strategic mission of work-related injury/illness prevention and the improvement of employee health, well-being and productivity in a global company.

Responsibilities:

- Develop and implement occupational health related programs and provide guidance and support on occupational health related issues, concerns, and initiatives to Stakeholders.
- Injury/illness medical case management in collaboration with on-site Occupational Health teams, Environmental Health and Safety teams, AbbVie Leave Management and 3rd party worker’s compensation administrator.
- Support the development and implementation of new and existing health clinics, both onsite and contract. Provide occupational health guidance and support to onsite and offsite health care providers as well as involvement when needed on third-party health care provider contracts.
- Work collaboratively with AbbVie business partners (ie: Crisis Management, Benefits, Environmental Health and Safety, Human/Employee Resources, Legal, and etc.) on various personal health and occupational health related initiatives such as, but not limited to: communicable disease initiatives, Total Worker Health, Case Management, Fleet Safety, accommodations, and etc.
- Develop new and / or update existing Global Occupational Health documents including medical surveillance procedures and technical guidance that will be implemented enterprise wide in response to changing business needs and emerging issues. Support ongoing Global Occupational Health strategies.
- Support occupational health activities required for Federal Motor Safety Administration.
- Provide oversight and direction related to the Electronic Medical Records systems used within AbbVie to document employee work related medical records/documentation.

Qualifications

- •Bachelor of Science with a focus in occupational health services or public health preferred
  •6-8 years of experience. At least two years in an occupational health clinic setting. Certified Occupational Health Nurse Specialist (COHN-S). Registered nurse with a current unencumbered state license
  •Strong working knowledge of OSHA regulations, FMLA, workers’ compensation case management and medical accommodation principles. In-depth knowledge of occupational health principals and practice. Strong knowledge of safety principles and regulations
  Relocation assistance is available for this role

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>)