Manufacturing & Production

Sanofi US

Launch Packaging lead

**Job Title**:Launch Packaging lead

- **Location:** Morristown, NJ

**About the Job**

Our ambition is to become industry leading in sustainable devices & packaging for injectable or solids.

As Launch Packaging Leader, you will be accountable for implementing our packaging vision & mission for new launches projects, execute the packaging strategy, and manage roadmaps and processes for primary, secondary, and tertiary packaging of injectable/solids. You will play a crucial role in achieving the company's ambition to become an industry leader in this specific area. You will work closely with the Global Area Head of Packaging to transform the organization's mindset and create a culture where end-to-end packaging for injectable or solids is part of our DNA and patient-centric approach.

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities**

- Drive45+NPI/new launch projects (solids and injectables) globally, leading a group of packaging engineers to meet Launch Project milestones on time, on budget and on quality (95% execution adherence).

- Lead packaging design and development for New Product Launches (NPL), driving innovation and sustainability across the portfolio, with 100% of newly developed packaging assessed against the 3Ps framework (Patient, Planet, Performance).

- Lead content and technical documentation standards for new product registrations (NCEs), ensuring filings meet global regulatory requirements and project timelines.

- Provide technical packaging leadership and analysis to R&D, Regulatory, manufacturing sites for the registration of products worldwide, representing GDPU and M&S on Global Project Teams and CMC sub-teams.

- Direct innovation programs for the search, evaluation and introduction of new packaging technologies to improve quality and compliance, advance sustainability (Eco-designinitiatives), improve efficiencies, reduce costs, eliminate waste and maintain supplycontinuity. Promotea culture of end-to-end packaging for injectable or solid within GDPU and related departments through communication, education, and recognition programs.

- Manage and develop the team responsible for launch packaging development.

**About You**

**Basic Qualifications**

- Bachelors degree in engineering, materials science, pharmaceutical sciences or other relevant scientific discipline.

- Minimum of 10 years of experience in driving packaging launch initiatives, packaging engineering or other related fields.

- Proven track record in managing injectable or solid packaging projects and teams

- Demonstrated ability to influence across functions and external networks, excellence in collaboration, and flexibility in approach

- Strong understanding of regulatory requirements for injectable or solid product packaging

**Languages:** Fluent in English, French is a plus

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.

- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeksgender-neutral parental leave.

- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale

- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#VHD

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

New Jersey

Signal Management Expert

**Job Title**: Signal Management Expert

- Location: Morristown, NJ

**About the job**:

As Signal Management Expert within our R&D team, you will be part of a cutting-edge safety group dedicated to optimizing the benefit-risk of our therapies so we can best serve our patients and consumers. The Signal Management team is an international group of process, method, and technology experts dedicated to supporting Global Safety Officers (GSO) and Pharmacovigilance Scientists (PVS) in monitoring product safety throughout the product lifecycle.

As Signal Management Expert (SME), you will be responsible for operationalizing the signal management process, including support of ongoing activities, continual improvement initiatives, metrics and oversight, and partnering with digital teams on the implementation of new systems with careful consideration to global regulations and stakeholder needs.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi**:

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities:**

- Collaborates with stakeholders across PSPV to ensure a compliant and efficient signal management process accounting for interdependencies with other PV and cross functional activities
- Manages the process and systems for routine signal detection and tracking of signal assessment
- Monitors external environment (i.e., regulations, literature, professional societies) for insights and innovation of the Sanofi signal management system
- Partners with Sanofi digital to administer, improve and implement digital systems used to perform signal detection and management
- Understands and evaluates signal detection data sources, methods, and tools to enhance Sanofis safety surveillance processes and systems
- Provides training and ongoing support to roles executing signal detection and signal management processes such as GSOs, PVS, Therapeutic Area Heads, Country Safety Heads
- Coordinates and oversees outsourced PV activities (i.e., maintenance of signal detection schedules, business administration of systems)

**About you**:

Experience:

- Minimum 2 years of experience in a pharmaceutical, biotech, or other regulated environment
- Evaluation, interpretation, and communication of scientific data
- Experience identifying, evaluating, and implementing process improvement initiatives including corrective and preventative actions (CAPAs)
- Working knowledge of pharmacovigilance and drug safety practices including US and EU regulatory requirements

Soft skills:

- Team player that communicates and performs effectively in a cross-functional, collaborative environment
- Self-motivated, able to prioritize on impact and a Sanofi first perspective
- Ability to influence across stakeholder groups and levels of the organization

Technical skills:

- Working knowledge of common data processing software and database systems
- Ability to map, analyze and measure processes
- Strategic thinker with ability to understand and assess impact of interconnected activities, projects, and systems
- Proficiency with MS applications

Education:

- Bachelor's degree in a healthcare, life sciences, or STEM discipline (e.g., Biology, Chemistry, Pharmacy, Public Health, or Biomedical Sciences)
- Preferred advanced degree such as Doctor of Pharmacy, Master of Science, PhD
- English (Business proficiency)

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#LI-Onsite

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

HVAC and Utilities Engineer

**Job Title**: HVAC and Utilities Engineer

- Location: Framingham, MA

**About the Job**

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities:**

- Jointly define with our Facility Management partner the optimal maintenance strategy to guarantee performance.
- Contribute to the design strategy by participating in the development of technical standards.
- Ensure regulatory compliance of equipment submitted and have any reservations resulting from inspections lifted. Ensure reporting to consolidate the site's regulatory situation.
- Anticipate developments (regulatory, technical, etc.) likely to influence the site's activities/performance.
- Analyze, advise, and make recommendations to improve the efficiency and effectiveness of technical solutions implemented.
- Challenge service delivery performance.
- Participate in deviation and root cause investigations as required.
- Communicate issues & resolutions to management, peers & maintenance team.
- Process Improvement Initiatives.
- Vendor Management.
- Own and support closure of HSE and Deviation CAPA Action Plans.
- Responsible for Emergency Response in the areas and systems they own.
- Participate in GOGEMBA site walk and own assigned GEMBA Actions.
- Help Hard Services Contract Supervisor and Head of Facility in monitoring and meeting KPI metric targets and compliance requirements in HSE, Quality and Work Management.

**About You**

**Basic Qualifications**

- Bachelor of Science degree in Engineering, Facilities Management, Mechanical Engineering, or related field with 3+ years of industry experience
- Extensive experience establishing and maintaining safe work practices in current Good Manufacturing Practice (cGMP) environments
- Wastewater Treatment Plant experience is preferred.
- Massachusetts Wastewater Treatment Plant Operator License preferred, or willigness to obtain.
- HVAC license preferred
- Refrigeration or EPA certificate preferred

**Core Competencies:**

- Demonstrated excellence in written and verbal communication across all organizational levels
- Proven ability to collaborate effectively in cross-functional team environments

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Massachusetts

Global Periodic Reporting Lead

**Job title:** Global Periodic Reporting lead

**Location:** Cambridge, MA / Morristown, NJ / Swiftwater, PA

**About the Job**

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

As Global Periodic Reporting Lead within our Pharmacovigilance team, you will ensure and develop robust , compliant, and controlled processes for Periodic Safety Report (PSR) authoring and vendor oversight. You will lead the Periodic Report Expert (PRE) Team through coaching and mentorship while managing the annual worldwide regulatory planning of PSRs for the entire company portfolio. You will develop and execute outsourcing strategies, uphold regulatory compliance, and drive process improvements to leverage efficiencies. Ready to get started?

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities:**

- Ensure and develop robust , compliant, and controlled processes for Periodic Safety Report (PSR) authoring and vendor oversight while upholding regulatory compliance expectation
- Lead the Periodic Report Expert (PRE) Team through coaching, mentorship, and development planning according to individual and organizational priorities
- Develop and execute outsourcing strategies for PSR authoring according to business criticality and resourcing needs
- Establish and maintain the annual worldwide regulatory planning of PSRs for the entire company portfolio (clinical and postmarketing)
- Manage PSR Planning Team with regard to PSR planning activities, resource allocation, and training needs
- Serve as system owner for the PSUR Web page Repository and tracking tool database
- Identify, implement, and support process improvements to leverage efficiencies and drive continuous improvement

**About You**

**Experience:**

- Experience in international pharmacovigilance for marketed drugs and/or projects under clinical development
- Proven track record in transversal collaboration
- Experience compiling and drafting PSRs and safety reports

**Technical and Soft Skills:**

- Excellent technical, clinical and critical analytical skills with keen understanding of clinical safety processes and analysis
- Strong understanding of global regulatory framework governing PSRs and worldwide pre and post marketing safety reporting regulations and ICH guidelines
- Leadership skills including team motivation, problem-solving, initiative-taking, and strong negotiation skills
- Process improvement experience (LEAN, Continuous Improvement) and project management of multifactorial activities with successful prioritization
- Excellent written and oral communication skills and computer literacy

**Education:**

- Bachelor's degree in health science or related field

**Languages:**

- Fluent English (written and spoken)

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#LI-Hybrid

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Eli Lilly and Company

HVAC Technician - Lilly Medicine Foundry

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**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

During the 2026–2029 startup and delivery phase, the HVAC Technician role will be dynamic, supporting project delivery, organizational growth, and developing systems and processes to support GMP operations. This will require significant collaboration, creativity, and resilience as the site grows to its full scale through start up.

**Responsibilities**

- Perform all work in compliance with global and local Safety, Environmental, and Quality procedures.
- Install, repair and perform preventative maintenance on basic heating and cooling systems (e.g., unit heaters, gas furnace, humidifiers, freezers).
- Install, repair and perform maintenance on complex heating and cooling systems (e.g., multi-zone heating, ventilating and air conditioning equipment, pneumatic, electric and electronic control systems).
- Balance flow in air handling systems, fume hoods and specialty applications to bring systems back into design specifications.
- Repair and perform preventative Maintenance on process and comfort chiller systems (e.g., water and glycol).
- Preventative maintenance on coils for HVAC
- Install, replace, and test filter systems (e.g., HEPA, frame filters).
- Inspect, validate, and repair HEPA filters by checking air velocity, checking static pressure readings, performing dioctyl phthalate (DOP smoke test) inspections, inspecting fan systems to check air flow/air balance and to make necessary adjustments to belts, motors and prefilters to maintain efficiency, checking and validating alarms, replacing differential pressure switches, and cleaning blower cabinets in hoods.
- Be certified in the use of CFC recovery equipment
- Maintain CFC records for usage and losses.
- Support communications between Operation shifts, Maintenance, Engineering, Automation, and site customers to keep them informed of any issues that could affect them.
- Document all work in alignment with cGMP Good Documentation Practices.

**Basic Requirements:**

- High School Diploma or equivalent
- 3+ years of mechanical experience in a HVAC industrial environment
- EPA Certification
- Valid Driver's License
- 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:**

- Maintenance experience in a manufacturing production environment or relevant field preferred.
- Experience with a regulated industry: FDA regulated industries preferred.
- Must be able to speak, read and write English at a sufficient level to communicate technical and business information effectively.
- Ability to follow written procedures while performing maintenance activities.
- Tasked with maintaining a safe work environment, operating safely, and supporting all HSE Corporate and Site Goals.
- Familiar with set-up and operation of Maintenance Shop hand tools & equipment: soldering and welding capability a plus.
- Ability to read and interpret mechanical & electrical prints/schematics.
- Must be able to effectively work in a team collaborative environment.
- Willingness to work out of your craft, as required.
- Proficiency in using CMMS.
- Microsoft Applications Knowledge.

**Other Information:**

- Position Location:
  - Initial location (temporary) at office in Indianapolis, Indiana.
  - Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
- Shift Information: 8 hours a day M-F, weekend on-call coverage as needed

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

$28.12 - $41.25

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

\#WeAreLilly

Indiana

Director Engineering - Synthetic Molecule Design and Development

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.

At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products. Our scientists and engineers develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing diverse talent and cultures are necessary to bring the next generation of life changing medicines to patients.

**Position Summary:**

Our team is looking for experienced, creative, and energetic candidates to lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, formulation scientists, and engineers.

**Responsibilities:**

- Possess fluent knowledge in unit operation design, process modeling, process equipment selection, and scale-up methodologies with a drive to challenge existing methods; create and apply cutting edge technology and novel platforms within a time constrained environment.
- Familiarity and working knowledge of modern synthetic organic chemistry.
- Demonstrate high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple disciplines; be able to apply these learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities.
- Lead and/or supervise the design and development of new synthetic routes for the manufacture of active pharmaceutical ingredients using the most modern technologies, including continuous processing, automated reaction screening, PAT, and modeling and simulation.
- Ability to lead a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver a challenging portfolio.
- Comfortable with scientific uncertainty and the ability to translate hypotheses into action.
- Encourage team members to take initiative and accountability to achieve goals; draws out and encourages others to share knowledge.
- Provide technical guidance in the scale-up and demonstration of new chemical processes in development and commercial scale equipment. Participate in technology transfer activities to CRO/CMO organizations and Lilly manufacturing to ensure processes are technically sound, well developed and characterized, and safe.
- Design laboratory experimentation in support of process design, definition, optimization, and technology transfer objectives. Ability to generate process (and property design) data based on a fundamental understanding of the underlying physical processes. Utilize advancements in technology (PAT) and modeling platforms to understand and direct experimental protocols.
- Plan and manage short term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
- Collaborate with internal and external manufacturing partners to develop robust chemical process that are readily amenable to efficient drug substance manufacturing.
- Collaborate closely with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory scientists to execute and deliver material and information for clinical trials and regulatory submissions.
- Embrace diverse thought, background, and experience to deliver innovative solutions.
- Possess strong communication (oral, written), organizational, and leadership skills.
- Supervise, mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
- Active participant in the external environment and the ability to recognize and apply external innovation and across the Lilly synthetic portfolio.
- Possess deep understanding of the external global regulatory climate and emerging requirements. Ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications.

**Basic Qualifications:**

- Ph.D. in chemical engineering or a closely related field with 8+ years of experience; or MS degree with 15+ years of experience.
- Experience developing chemical processes the from mid-development cycle (proof of concept) to product commercialization required
- Experience with technical transfer of processes into manufacturing operations required

*\*Experience within the pharmaceutical sector is desired; however, other relevant experience may meet expectations. Prior experience in the development of an active ingredient and associated formulated product is acceptable. Relevant industrial sectors include agrochemicals, nutraceuticals, specialty chemicals, and personal care products.*

**Additional Skills/Preferences:**

- Experience with authoring regulatory submissions and responding to regulatory questions.
- Experience with modeling and simulation tools, data analytics, and predictive analytics.
- Experience with online and offline analytical techniques and process analytical technologies (PAT).
- Strong technical skills to supply business value.
- Creativity and ability to transform ideas into marketable products and processes.
- Knowledge and experience with management of a technical project.
- Demonstrated leadership capabilities especially in a team environment.
- Demonstrated ability to drive and accept change.
- Demonstrated success in persuasion, influence and negotiation.
- Good interpersonal skills and a sustained tendency for collaboration.
- Ability to prioritize multiple activities and manage ambiguity.
- Ability to influence others to promote a positive work environment.
- Understanding and awareness of the external scientific and regulatory landscape.
- Demonstrated initiative and risk-taking.
- Demonstrated technical proficiency and ability to create ideas for future work plans.
- Established external publication record.

**Additional Information:**

- Travel: 0 -10%
- Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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

$151,500 - $264,000

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

Engineer - Design Lead

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

**Organization Overview**

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.

The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering and Continuous Improvement, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, construction and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will support an expansion in supply of existing medicines or making the supply chain more robust. The Design Lead (DL) will serve in the following capacity:

**Responsibilities:**

- Lead in the identification of the applicable Engineering Design Standards, Engineering Functional Standards, Engineering Specifications and Regulatory requirements and guidance (both internal and external).
- Be responsible for the overall design delivery for capital project(s).
- Coordinate all design for the Project Manager during all design phases of the project and be responsible in delivering the conceptual design review and basic design review.
- Direct the development of the design requirements.
- Assist in development and maintenance of the design schedule to meet the project needs.
- Participate in the selection of the A/E firms.
- Coordinate with A/E firms to develop earned value progress systems to measure progress by discipline (monitor work versus invoice amounts).
- Expedite design decisions and coordinate information flow between the design team and system owners.
- Be responsible for ensuring the design meets approved intent through interactions between the design firm, design specialists, engineering tech center disciplines, and end user/customer.
- Be responsible for design activities and governance, resolving design-related problems.
- Examine areas of inefficiency and develop strategies for improvement to direct the design team to meet or improve on the design hours plan.
- Assist in the development of standard operating procedures, project delivery work instructions, and/or best practices related to design/verification and ensure they remain current with industry best practices.
- Review and approve along with the respective Project Manager the key design project personnel (both internal and external resources).
- Work with Engineering Tech Center resources and other key project team technical/constructability resources to address and resolve design issues.
- Ensure replication is achieved during design when applicable.
- Support the Project Manager for value engineering exercises efforts to maximize project opportunities.
- Review design-related invoices prior to approval and participate in KPI reviews/assessments.
- Participate in the selection of the verification professional services.

**Basic Requirements:**

- BS in Engineering.
- Minimum of 10-years manufacturing and/or engineering experience in support of pharmaceutical or API (active pharmaceutical ingredient) networks.
- 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:**

- BS in Chemical or Mechanical Engineering.
- Pharmaceutical process or project engineer experience.
- Strong project management skills.
- Ability to effectively facilitate conflict to resolution.
- Ability to influence all levels of the project and site personnel.
- Understanding of the capital project delivery process, A/E design activities, and the understanding of the available Lilly technical resources (user reps, Engineering Tech Center resources, and design specialists).
- Demonstrated values that are consistent with the Lilly values.
- Able to frame complex decisions/analyses, facilitate to a decision, and implement according to the plan.
- Ability to create creditability and influence to align decision agreements between site(s), corporate engineering, A/E firm decision-makers, and stakeholders who have differing opinions.
- Experience facilitating issue resolution, anticipating scope changes, and implementing projects safely with quality, speed and value.
- Willingness to relocate and/or travel to locations outside of home state/country and have the demonstrated ability to work from long distances with little supervision.

**Additional Information:**

- Travel can be both domestic and international, on average about 25%, depending on the phase of the project.
- The potential of co-location at the A/E firm or the job site to support C&Q activities for periods of time could occur based on project needs.

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

GRAIL Inc

Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the Bay Area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit [grail.com](<http://grail.com/>)

The **Director, Regulatory Affairs - Advertising, Promotional and Labeling** provides strategic leadership and operational compliance for the company’s product messaging. The Director serves as a senior regulatory subject-matter expert and strategic business partner, who leads cross-functional teams in developing promotional materials to ensure compliance with global regulatory markets, while capturing potential regulatory risks. This role will also partner with executive leadership to guide regulatory strategy for GRAIL’s portfolio and drive business critical decisions.

This is a hybrid role based in Sunnyvale, CA. Our current flexible work arrangement policy requires that a minimum of 40%, or 16 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with the team and business needs and could exceed the 40% requirement for the site.

**Responsibilities:**

- Provide cross-functional leadership and representation for Regulatory Affairs on the Promotional Materials Review Committee, ensuring all promotional materials are compliant with regulatory requirements while shaping and aligning with overarching corporate and portfolio strategies
- Experience leading or supporting product promotion and launches is preferred.
- Define and shape innovative, compliant regulatory strategies and solutions for highly complex and business-critical promotional concepts, enabling business objectives while proactively mitigating regulatory risk across the portfolio
- Lead the oversight and evaluation of product claims to ensure scientifically robust and compliant messaging
- Establish and advance the strategic framework for the advertising and promotion process through developing SOPs to drive continuous improvement, governance, and operational compliance across the organization
- Influence and drive alignment with senior leadership, building consensus and shaping decisions to balance business objectives with regulatory requirements
- Demonstrated ability to lead and foster a culture of continuous learning and process improvement across the organization
- Exceptional communication and influencing skills
- As the organization evolves, the employee must be adaptable to taking on additional responsibilities, new technologies, or cross-functional projects to meet changing business needs

**Adaptability and Growth Expectation**

As our organization continues to evolve and grow, this role may require flexibility in responsibilities and duties. Employees should expect that their role may expand, shift, or be modified to meet changing business needs, strategic priorities, and organizational objectives.

This may include:

- Taking on additional responsibilities.
- Participating in cross functional projects and initiatives.
- Adapting to new technologies, processes, or methodologies.
- Supporting other departments or teams during periods of high demand.
- Contributing to special projects or temporary assignments as needed.

These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

**Required Qualifications:**

- Advanced degree in molecular biology, genomics, or diagnostics; PhD preferred.
- 15+ years of relevant regulatory affairs or related industry experience; Master's degree with 12+ years, or PhD with 8+ years
- Prior regulatory affairs experience in medical devices, clinical laboratory and/or diagnostics
- Proven record of success leading cross-functional teams to resolve highly complex promotional regulatory challenges, driving innovative, compliant solutions across the portfolio
- Demonstrated level of knowledge of global regulations, guidances, and standards, particularly around advertising and promotion

**Preferred Qualifications:**

- Exceptional leadership skills, with the ability to inspire, align, and influence at all organizational levels.
- Strong strategic foresight with the ability to anticipate regulatory and policy shifts and align company direction.
- Excellent communication, negotiation, and executive presentation skills.
- Proven ability to lead complex programs and drive portfolio-level decision-making.
- Advanced proficiency with regulatory systems, submission tools (e.g., eCTD), and enterprise compliance platforms.
- Commitment to developing talent and building long-term organizational capability.

The expected, full-time, annual base pay scale for this position is $189k-$271k.

At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.

At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at \[email protected\] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

California

Senior Scientist, Operations Investigation Team (OIT) #4936

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the Bay Area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit [grail.com](<http://grail.com/>)

The Senior Scientist is an experienced scientific individual contributor responsible for investigating platform and assay performance issues, identifying root causes, and developing technical solutions to improve platform reliability and operational performance. As a member of the Operations Investigation Team (OIT), this role independently conducts scientific investigations, collaborates across functions, and drives continuous improvement through data-driven problem solving and process optimization.

This position works on-site full-time, 5 days/week at our office located in Durham, NC

**Responsibilities:**

- Independently design, plan, and execute experiments to investigate platform performance issues and support troubleshooting efforts.
- Analyze experimental data, identify root causes, and develop scientifically sound recommendations.
- Develop, optimize, and troubleshoot experimental methods, workflows, and analytical tools to improve platform robustness, reliability, and efficiency.
- Investigate sources of technical variability and recommend corrective and preventive actions.
- Prepare technical reports, presentations, and investigation summaries to communicate findings and recommendations.
- Collaborate with cross-functional teams, including R&D, Operations, Engineering, Quality, Manufacturing, and Data Science, to resolve platform-related issues.
- Provide technical expertise in experimental design, troubleshooting strategies, and data interpretation.
- Contribute to the development of new technologies, analytical tools, and process improvements that enhance platform performance.
- Ensure compliance with laboratory safety, quality, and applicable regulatory standards.
- These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

**Required Qualifications:**

- Ph.D. in Molecular Biology, Biochemistry, Biotechnology, or a related scientific discipline with 2+ years of relevant experience; OR Master's degree with 5+ years of relevant experience; OR Bachelor's degree with 8+ years of relevant experience.
- Strong expertise in molecular biology, NGS technologies, assay development, or related experimental disciplines.
- Experience with laboratory or biotech automation platforms (e.g., liquid handlers, robotic workcells, automated sample-processing systems) is highly desirable.
- Proven experience independently designing and executing experiments and solving complex technical problems.
- Demonstrated experience conducting root-cause investigations and developing practical technical solutions.
- Strong scientific communication and technical presentation skills.
- Experience working in regulated laboratory environments is preferred.

**Preferred Qualifications:**

- Advanced troubleshooting, analytical, and root-cause investigation skills.
- Strong experimental design and data interpretation capabilities.
- Ability to manage multiple investigations and priorities in a fast-paced environment.
- Strong collaboration and communication skills with cross-functional teams.
- Innovative, self-motivated, and results-oriented with a continuous improvement mindset.

**Physical Demands and Environment:**

- Work may be performed in laboratory and office environments with exposure to biological samples, chemicals, and laboratory equipment.
- Requires appropriate personal protective equipment (PPE).
- May require extended hours to support critical investigations.
- Regular laboratory activities, including pipetting and operation of laboratory instrumentation.

The expected, full-time, annual base pay scale for this position is $122k-$147k.

At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.

At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at \[email protected\] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

North Carolina

Intellia Therapeutics

Manager CMC Program Operations

**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.

As Intellia continues to advance its pipeline, this newly created role reflects the organization's commitment to operational excellence, scalable project management, and digital transformation within CMC.

The Manager, the CMC Program Operations will serve as the operations and digital enablement lead for CMC teams, partnering directly with the Commercial CMC Team Lead to build and maintain integrated project plans, dashboards, and reporting tools that drive execution. This role goes beyond traditional project coordination, it is responsible for designing and deploying practical, generative and agentic AI-enabled tools (e.g., smart dashboards, auto-generated status reports, risk-flagging models) that improve visibility, reduce manual tracking burden, and accelerate decision-making across CMC workstreams. The Manager will drive cross-functional coordination, track program risks, manage regulatory commitment timelines, and act as the primary operations point of contact for the commercial CMC teams, with opportunity to influence broader platform and portfolio operations.

**Duties/Responsibilities**

- Build and maintain a master CMC project plan (MS Project, Smartsheet, or equivalent), identifying task interdependencies, critical path, and monitoring mechanisms for schedule risk.
- Design and implement AI-assisted or automated tools (e.g., dashboard automation, natural-language status summarization, predictive risk flagging) to reduce manual reporting effort and increase real-time visibility into program health.
- Publish recurring dashboards and executive-ready reporting to align the team on progress, critical path changes, and emerging risks.
- Actively participate in CMC team meetings — set agendas, capture minutes, track action items, and drive follow-through.
- Maintain the CMC risk register; apply a structured framework for risk identification, scoring, mitigation, and escalation, and facilitate risk review forums.
- Partner with Regulatory, Process Development, Manufacturing, Supply Chain, and Quality representatives to ensure RtQ/PAC commitments are clearly defined, assigned, and tracked.
- Coordinate with RegCMC on post-approval commitment (PAC) tracking and provide leadership with regular status reporting, flagging gaps or delays.
- Identify opportunities to modernize CMC operations workflows through digital tools and automation; pilot and scale successful solutions across the broader CMC/pipeline organization.
- Establish scalable, repeatable processes and tooling standards that improve transparency, accountability, and execution speed across CMC programs.
- Lead or contribute to special projects involving process improvements, change management, and operational efficiency.

**Requirements**

**Skills/Abilities**

- Strong project management fundamentals (MS Project, Smartsheet, or similar) with proven critical-path and risk-management experience.
- Demonstrated experience using AI/automation tools to build practical operational solutions (e.g., using generative AI, low-code/no-code platforms, scripting, or BI tools like Power BI/Tableau to automate reporting, summarize data, or flag risks).
- Working knowledge of GMP, quality, supply chain, and regulatory requirements in a biopharma/cell & gene therapy context.
- Proven ability to influence without authority across matrixed, cross-functional teams.
- Excellent written/verbal communication and stakeholder management skills.
- High attention to detail, strong organizational skills, and comfort operating in a fast-paced, ambiguous environment.

**Education / Certifications**

Bachelor’s degree in a relevant field, PMP certification preferred

**Experience**

- 6+ years in biopharmaceutical/life sciences, including CMC development (cell & gene therapy preferred), with 2+ years in dedicated CMC or operations project management.

- Hands-on experience building or deploying AI-enabled or automated tools to support program/operations reporting is strongly preferred

**Physical Requirements**

N/A

\#LI-KO1

**_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 $141,698.00 - $173,186.00 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/>).

Senior Scientist - Small Molecule and Oligonucleotide Process Sciences

**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.

**How You Will Achieve More:**

As a successful candidate you will join the sgRNA Process Development Group as part of the larger Oligonucleotide and Lipid Process Sciences team within Technical Operations/CMC. As SME for the sgRNA upstream process and process chemistry you will be providing technical and operational support across all life-cycle stages for Intellia’s assets from emerging pipeline through commercial-stage activities. You will help drive process design, development, characterization and finally tech transfer of GMP-ready processes while serving as a key technical partner across cross-functional teams within Intellia and with external partners as needed. In this role you are expected to mentor junior staff and drive continuous improvement across our processes and operations.

**Responsibilities:**

*Process Development & Technical Execution*

- Lead development, optimization and characterization of solid-phase oligonucleotide synthesis (upstream focus), with emphasis on scalability and tech. transfer (OP100 scale)
- Design and execute process characterization studies/DoEs and troubleshoot analytical data
- Support downstream purification processes to improve yield, purity, and reproducibility
- Support MSAT team with tech transfer and process validation activities as well as continuous process verification as needed

*Operational Execution & Documentation*

- Track milestones, dependencies, and risks across concurrent PD workstreams
- Manage day-to-day lab resourcing and prioritization
- Coordinate with external manufacturing & supply chain as well as CDMOs in support sgRNA and lipid manufacturing as needed
- Author and review SOPs, batch records, development reports, sections for regulatory filings as well as process validation and change control documentation

*Mentorship & Collaboration*

- Represent Process Development and provide updates to cross-functional teams using effective communication to both technical and non-technical audiences
- Serve as the team process chemistry SME across the matrix for oligonucleotide and small molecule synthesis; mentor and train junior scientists; and collaborate with stakeholders that support other modalities.

**About You:**

- Solid expertise in phosphoramidite and oligonucleotide process chemistry with hands-on experience in automated synthesizers (OP100, Oligosynt platforms) and HPLC
- Strong organic chemistry foundation with working knowledge in small molecule manufacturing processes is an advantage
- Proficiency in HPLC and LC-MS for oligonucleotide characterization and analytical troubleshooting
- Excellent technical writing skills; track record of authoring SOPs, reports, and regulatory documents. Being highly organized with ability to manage multiple concurrent workstreams and drive priorities independently
- PhD in Organic Chemistry, Biochemistry, Biotechnology, or related field
- MS or BS in a related scientific discipline
- Ph.D. or M.S. in Chemistry, Organic Chemistry, Nucleoside Chemistry or related discipline with minimum 2 (PhD) or 8 (M.S.) years' experience, preferably in oligonucleotide field.
- Hands-on experience with solid-phase oligonucleotide synthesis and operation of lab-scale synthesizers; familiarity with GxP operations, quality systems and the pharmaceutical development lifecycle
- Experience driving multiple workstreams internally with cross-functional stakeholders as well as with external partners

\#LI-On-Site

**_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 $136,800.00 - $167,200.00 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/>).

Civica Rx

Supervisor, Manufacturing Support - 2/2/3 Days (580)

**Job Description:**

The Manufacturing Support Supervisor will play a role in facility start-up and commercialization, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica site in Petersburg, VA. This position will hire, develop, and support a team of manufacturing associates through equipment qualifications, identifying and improving processes, operating manufacturing equipment, and owning documentation. This position will provide new process training to the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of high-quality injectable products in line with the Civica culture and vision for what is in the best interest of the patient. This is a 6:00 AM – 6:30 PM, 2-2-3 work schedule.

**Essential Duties and Responsibilities:**

- Under the Director of Manufacturing’s direction, actively participate in new equipment and process qualifications.
- Demonstrated ability to act as subject matter expert in manufacturing processes, including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).
- Serve as the escalation point for their group, take accountability and ownership for business, technical, and compliance decisions
- Maintain Civica’s right to operate:
- Maintain inspection readiness and serve as SME during inspection tours
- Ensure staff are appropriately trained and qualified for the activities they perform prior to execution
- Ensure systems and processes are properly executed and maintained to ensure staff’s safety, product quality, and continuity of supply
- 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, process efficiencies, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing tools and techniques.
- Mentors, coaches, and teaches Manufacturing Associates in the use of change management/control techniques to ensure timely completion of projects.
- Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of the timely resolution of deviations/discrepancies related to Manufacturing.
- Identifies corrective and preventive actions (CAPA) and leads projects to completion within project timelines. Verify the effectiveness of CAPA by post-project data collection and analysis.
- Demonstrated ability to act as subject matter expert in manufacturing processes, including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).
- Flex schedule to meet commitments and achieve milestones related to projects, production, and other demands of the role.
- Ability to work on-site is required
- Maintain accuracy of and approve staff’s timecards

**Basic Qualifications and Capabilities:**

- Bachelor's degree with 4+ years of demonstrated ability in a cGMP FDA, cGMP, ISO, or other regulated production environment. An associate’s degree and 6 years of cGMP production experience may be considered.
- Experience with Autoclaves and Parts Washers.
- 1+ years of supervisory experience in a GMP manufacturing environment.
- Experience in a process improvement environment, including change management and leading teams.
- Lean Manufacturing/Six Sigma Green Belt Certification preferred.
- Strong writing and documentation skills.
- Self-directed with effective analytical and problem-solving skills.
- Strong interpersonal, collaboration, communication, and leadership skills.

**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.

Virginia

Process Engineer II (238)

**About Civica:**

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at [**www.civicarx.org**](<http://www.civicarx.org/>)

**Job Description**

The Process Engineer II will play a critical role in bringing the Civica Petersburg, VA facility into a production-ready state, and in facility and equipment design through commercialization for a newly announced facility expansion for biologics. Scope for the expansion includes a dedicated high-speed cartridge filling line, substantial upgrade to critical utilities services, and dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities.

In the project delivery and startup phase of the project (currently in progress through 2025), the

Senior Process Engineer will be dynamic as we endeavor to support the startup, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

The Senior Process Engineer will act as a bridge between the project planning phase and ongoing operations by assuming System Owner responsibility for one or more manufacturing systems. In this role, the successful candidate will work closely with Validation, Manufacturing, and Quality Assurance to ensure availability, support, and maintenance of those system(s) throughout their lifecycle, and serve as subject matter expert internally and in regulatory inspections for production processes utilizing those systems.

**Essential Duties and Responsibilities**

- You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting.
- Provide technical expertise on CQV activities and ensures compliance to regulatory requirements, industry best practices, and Engineering standards.
- Participate directly in the Engineering process to develop and institute technical and procedural controls in the process design.
- Accountable for CQV activity for assigned systems, including all phases: identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
- Execute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.
- Anticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the Manufacturing team.
- Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
- Interpersonal skills to manage interactions and drive results across a range of business functions, education levels, and cultural backgrounds within the site. Extends to external communication with system vendors.

**Basic Qualifications and Capabilities**

- Bachelor’s degree in Engineering required.
- Strong mechanical aptitude.
- Demonstrated ability to solve technical problems and implement projects.
- Excellent interpersonal and communication skills, and fluency in English.
- Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
- Interact well with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects with minimal required direction from his/her supervisor.
- Willingness to adapt to changing priorities as project demands change.

**Preferred**

- 5+ years of experience in sterile injectables, drug-device combination products, or biologics.
- SME-level knowledge of drug product processing equipment (e.g. single-use mixers and stainless steel formulation vessels, parts washers, autoclaves, component processors, aseptic filling equipment – vials, pre-filled syringes, and cartridges – isolators with VPHP decontamination, filter integrity and isolator glove integrity testers).
- Direct experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.
- Familiarity with cleaning validation and/or process validation.
- Previous work at greenfield sites or substantial facility expansion projects.

QA Supervisor - Operations - 1st shift (369)

**Job Overview**

The Quality Assurance Supervisor-Operations will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuing excellence in quality and compliance. The Petersburg site serves as Civica’s new fill-finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications.

The role is essential to ensure the Petersburg site’s manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines.

Responsibilities of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations from the onset of building and qualifying the facility, leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

Responsibilities also include, but are not limited to, shop floor oversight and the generation, review, and/or approval of policies, procedures, reports, batch records, and other records necessary to support the design, implementation, and maintenance of manufacturing processes that meet or exceed FDA requirements.

**Essential Duties and Responsibilities:**

· Working across functions, establish and maintain the site’s quality systems related to manufacturing operations to enable reliable supply of quality generic medications to patients.

· Promote a quality mindset and quality excellence approach to all activities.

· Promote a safety mindset and focus on safety for all operational activities.

· Responsible for operational compliance aspects of sterile fill-finish manufacturing of products, including but not limited to aseptic process simulations, terminal sterilization, batch record review, batch disposition, and shop-floor quality.

· Ensure that all aspects of the handling and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.

· Establish and maintain Standard Operating Procedures and training consistent with CGMPs for QA shop-floor support.

· Provide leadership, direction, and support to ensure shop floor associates and operators are qualified, achieve a high level of competence, are motivated, and carry out their duties in a safe manner.

· Maintain written procedures and associated records for personnel qualification and training and support the delivery of compliance training sessions.

· Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.

· Support, review and approve equipment qualifications and product and process transfers, including validation, from development and/or other manufacturing sites.

· Establish and maintain Standard Operating Procedures, and training to ensure raw materials, excipients, APIs and components are qualified, and their suppliers are approved in accordance with Civica and GMP requirements.

· Establish and maintain Standard Operating Procedures and training to ensure that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labeling and drug products are released in accordance with the registered specifications.

· Responsible for Quality shop-floor oversight including real-time batch record review, response to deviations and implementation of corrective actions.

· Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.

· Participate in quality risk analysis.

· Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

· Travel is limited but may occasionally be required.

**Basic Qualifications and Capabilities:**

· Bachelor’s degree in a scientific discipline with a minimum of 5+ years of Quality/CGMP experience in the pharmaceutical industry. Experience in sterile injectable manufacturing and packaging operations is required.

· Strong project management, organization, and execution skills with a proven track record of shop floor manufacturing.

· Quality assurance experience across the product development and commercialization lifecycle.

· Participation and leading activities to support regulatory agency inspections required.

· Excellent interpersonal and written communication skills and experience using various software/electronic applications required.

· Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.

· Ability to work autonomously and within established guidelines, procedures, and practices.

· Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.

· Continuously looking for opportunities to learn, build skills, and share knowledge with others.

· Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.

· Prior experience in a supervisory role highly desired.

**Physical Demands and Work Environment:**

The physical demands described here are representative of those required of an employee to successfully perform the essential functions of this position. Reasonable accommodations 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 hands or fingers to 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 25 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.

Manufacturing Technician 2nd shift (w/ 10% differential pay)

**About Civica:**

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at [**www.civicarx.org**](<http://www.civicarx.org/>)

**Position Summary**

Entry-level Manufacturing Technician responsible for supporting pharmaceutical production processes, including weighing and dispensing materials, compounding bulk solutions, and operating filling and packaging equipment for cartridges, prefilled syringes, vials, and related lines.

**Essential Duties and Responsibilities**

- Under the Manufacturing Lead and/or Supervisor’s direction, support manufacturing operations to meet strategic department objectives.
- Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas.
- Replenish manufacturing components, materials, and supplies in all processing areas.
- Transport bright stock and finished product to and from staging as required according to manufacturing schedule.
- Perform equipment cleaning and preparation for sterilization. Operate sterilizer equipment to provide format parts for filling equipment.
- Clean, set up, and decontaminate material transfer isolator.
- Clean, set up, and operate component processing equipment.
- Clean, set up, and operate terminal sterilizer equipment.
- Clean, set up, and operate weighing and compounding equipment.
- Weigh APIs and excipients according to batch record instructions.
- Compound bulk drug product per standard operating procedures and batch record instructions.
- Clean, set up, and operate packaging equipment.
- Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices.
- Adhere to all safety regulations.
- Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
- Perform other duties as assigned by manufacturing management.

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

- High school diploma or equivalent required.
- Coursework or bachelor’s degree in a Life Science discipline preferred.
- Good reading and writing skills with the ability to perform basic to advanced mathematical calculations.
- Ability to read, understand, and follow written procedures accurately.
- Hands-on experience manipulating, handling, or assembling products in a manufacturing or production environment strongly preferred.
- Previous pharmaceutical manufacturing experience preferred.
- Willingness to work overtime, weekends, and adjust schedules as needed.

**Benefits:**

- **_Upon completion of 6 month paid training program:_**
  - Leading pay and annual performance bonus for all positions
  - All employees enjoy generous paid time off including 10 paid holidays
  - Civica pays 100% of health insurance for the employee
  - Health Insurance, Dental Insurance, Vision Insurance
  - Guaranteed 401K contribution
  - Life & Disability Insurance
  - Employee Referral Awards

2nd shift: 3pm to 11:30pm | Monday - Friday

Manufacturing Technician 1st shift

**About Civica:**

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at [**www.civicarx.org**](<http://www.civicarx.org/>)

**Position Summary**

Entry-level Manufacturing Technician responsible for supporting pharmaceutical production processes, including weighing and dispensing materials, compounding bulk solutions, and operating filling and packaging equipment for cartridges, prefilled syringes, vials, and related lines.

**Essential Duties and Responsibilities**

- Under the Manufacturing Lead and/or Supervisor’s direction, support manufacturing operations to meet strategic department objectives.
- Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas.
- Replenish manufacturing components, materials, and supplies in all processing areas.
- Transport bright stock and finished product to and from staging as required according to manufacturing schedule.
- Perform equipment cleaning and preparation for sterilization. Operate sterilizer equipment to provide format parts for filling equipment.
- Clean, set up, and decontaminate material transfer isolator.
- Clean, set up, and operate component processing equipment.
- Clean, set up, and operate terminal sterilizer equipment.
- Clean, set up, and operate weighing and compounding equipment.
- Weigh APIs and excipients according to batch record instructions.
- Compound bulk drug product per standard operating procedures and batch record instructions.
- Clean, set up, and operate packaging equipment.
- Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices.
- Adhere to all safety regulations.
- Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
- Perform other duties as assigned by manufacturing management.

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

- High school diploma or equivalent required.
- Coursework or bachelor’s degree in a Life Science discipline preferred.
- Good reading and writing skills with the ability to perform basic to advanced mathematical calculations.
- Ability to read, understand, and follow written procedures accurately.
- Hands-on experience manipulating, handling, or assembling products in a manufacturing or production environment strongly preferred.
- Previous pharmaceutical manufacturing experience preferred.
- Willingness to work overtime, weekends, and adjust schedules as needed.

**Benefits:**

- **_Upon completion of 6 month paid training program:_**
  - Leading pay and annual performance bonus for all positions
  - All employees enjoy generous paid time off including 10 paid holidays
  - Civica pays 100% of health insurance for the employee
  - Health Insurance, Dental Insurance, Vision Insurance
  - Guaranteed 401K contribution
  - Life & Disability Insurance
  - Employee Referral Awards

1st shift: 7am - 3:30pm | Monday - Friday

Maintenance Technician, Process Equipment (# 318, # 605)

**About Civica:**

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

*Who suffers most? Patients.*

**Civica** is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at [www.civicarx.org](<http://www.civicarx.org/>)

**Position Summary**

The Maintenance Technician, Process Equipment is responsible for driving compliant results in a GMP pharmaceutical manufacturing environment by directly supporting a wide range of service disciplines covering pharmaceutical process equipment such as, but not limited to: fill lines, isolators, parts washers, autoclaves, container closure processing equipment, formulation vessels, labeling equipment, and various lab equipment utilized in the production environments. The Maintenance Technician, Process Equipment, operates in a highly technical environment that requires experience specifically in maintaining safe and reliable production activities. The Maintenance Technician, Process Equipment, applies critical thinking and considers all business-impact factors before taking job-related actions that could lead to unintended consequences, such as unsafe events, equipment failure, and other risks. The Maintenance Technician, Process Equipment, should be able to apply independent judgment and perform in a small-company environment where rapid changes occur. The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive mindset, driving a positive team culture.

These positions follow a 2-2-3, 12-hour day schedule: 6:00 PM-6:30 AM - 2 days on, 2 days off, 3 days on, 2 days off, 2 days on, 3 days off.

**Essential Duties and Responsibilities**

- Support the day-to-day production activities in the production area. First line of response in case of production equipment malfunction.
- Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.
- Partner with engineering, calibration, and spare parts teams to ensure proper inventory of key spare parts.
- Partner with engineering in the development and/or revision as required, of preventive maintenance (PM) instructions of production equipment.
- Support the coordination and execution of calibrations and preventative maintenance activities.
- Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors as needed to reach problem resolutions.
- Proactively work with supports teams Ein developing solutions for equipment issues.
- Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner.
- Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).
- Collaborate with Manufacturing, Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
- Support the onboarding and technical training of Manufacturing staff on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and formulation vessels.
- Assist R&D and MSAT on new product introduction and technology transfer activities.
- Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.
- Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.
- Periodically on call to monitor and respond to manufacturing equipment repairs and issues.
- Other duties as assigned.

**Basic Qualifications (Knowledge, skills, and abilities)**

- High school diploma with 4 years of experience in executing maintenance to manufacturing equipment, or an associate’s degree or higher in Pharmaceutical Sciences, Engineering, or a related field is preferred.
- Experience with sterile fill-finish manufacturing.
- Knowledge of GMP, regulatory requirements, and industry best practices.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Experience in a continuous process improvement environment, including change management.
- Experience in using Computerized Maintenance Management Systems.
- Strong communication and collaboration skills, committed to meeting high-quality standards.

**Preferred Qualifications**

- Knowledge of high-speed aseptic filling and isolator barrier system technology.
- Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
- Proficiency in Microsoft Office Suite.

**Physical Demands and Work Environment**

The physical demands described here are those an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation may be provided 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 must frequently use their hands or fingers to handle, feel, or control 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, a drug-free workplace, and complies with applicable ADA regulations.

Amgen

Process Development Associate- Attribute Sciences

**Join Amgens Mission of Serving Patients**

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

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

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

**Process Development Associate- Attribute Sciences**

**What you will do**

Lets do this. Lets change the world. Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses.

Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic biologic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), live oncolytic viruses, and synthetic medicines.

As a PD Associate, the candidate will participate in protein characterization studies to support regulatory filings using High Performance Liquid Chromatography (HPLC) / Ultra Performance Liquid Chromatography (UPLC) and mass spectrometry (MS). The candidate will also work to develop, qualify, and transfer analytical methods to Quality Control, and optimize and troubleshoot existing methods.

They will collaborate with other process development departments to support commercial process development and process characterization studies in support of marketing applications.

This position is located at our Thousand Oaks, CA site.

**Key responsibilities:**

Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis platforms

Perform chromatographic fractionation, peptide mapping, intact mass, and other LC-MS studies to support product characterization and comparability studies

Author results in laboratory notebooks and method development reports, interfacing closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods

Participate in the maintenance of Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase appropriate good manufacturing practices (GMP) environment

With a focus toward evaluation of critical quality attributes, coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions

Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways

Perform evaluation of novel platform analytical technologies to help drive innovation

Perform experiments to help answer questions from health authorities

Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications

**What we expect of you**

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

**Basic Qualifications:**

Bachelors degree

OR

Associates degree and 2 years of Scientific experience

OR

High school diploma / GED and 4 years of Scientific experience

**Preferred Qualifications:**

- Scientific background in method development and product characterization for therapeutic proteins
- Preferred Degree in Biochemistry, Analytical Chemistry, Protein Chemistry or related subject area
- Excellent written and verbal communication skills, ability to multitask, efficiently plan and follow through on complex projects
- A self-starter, and someone who values working in teams

**What you can expect of us**

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

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

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

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

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

**careers.amgen.com**

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

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

**Sponsorship**

Sponsorship for this role is not guaranteed.

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

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

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

Manager - Business Operations Partner - Neurology & IgG4-RD

**Join Amgens Mission of Serving Patients**

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

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

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

**What you will do**

Lets do this. Lets change the world. In this vital role, you will support the UPLIZNA (Neurology & IgG4-RD) commercial organization by leading defined business operations workstreams, developing insights that inform decisions, and coordinating execution across functional partners. You will help translate brand priorities into clear plans, track business performance, and strengthen the operating practices that enable the team to deliver for patients.

Working closely with the UPLIZNA Business Operations Associate Director, Sales, Marketing, Patient Services, Business Analysis and Insights, Finance, and other cross-functional partners, you will bring structure to business questions, synthesize information, and provide practical recommendations. This role requires strong analytical judgment, disciplined project management, clear communication, and the ability to influence without direct authority.

**Responsibilities include:**

**Business Partnership and Operational Support**

- Partner with UPLIZNA commercial functions to understand business priorities, operational needs, and interdependencies.
- Support brand and functional leaders with structured analysis, coordination, and follow-through on agreed priorities.
- Develop a working knowledge of the UPLIZNA business, customers, market dynamics, and commercial operating environment to inform day-to-day decisions.
- Proactively identify execution issues, dependencies, and opportunities within assigned areas, and bring forward practical options and recommendations.
- Build effective working relationships across a complex, matrixed organization and help maintain alignment among project stakeholders.

**Business Performance Insights & Decision Support**

- Partner with Business Analytics & Insights, Finance, and cross-functional stakeholders to monitor performance and answer priority business questions.
- Synthesize performance data, market information, and stakeholder input to identify trends, risks, and opportunities.
- Conduct structured analyses and scenario assessments, translating findings into actionable recommendations.
- Develop executive-ready presentations, business reviews, and narratives that make complex information clear and support productive leadership discussions.
- Establish and track relevant performance measures for assigned initiatives, and recommend actions based on results.

**Strategic Planning & Execution**

- Support UPLIZNA planning processes, including brand planning, business reviews, forecasting, Long Range Strategy, and Quarterly Business Reviews.
- Independently lead defined strategic and/or operational initiatives and special projects/ business cases from planning through implementation.
- Develop project plans with clear deliverables, owners, milestones, risks, dependencies, and measures of success.
- Coordinate cross-functional working sessions, document decisions, and ensure actions are completed on schedule.
- Monitor progress, resolve routine execution issues, and escalate material risks or decisions to the appropriate leaders.
- Manage multiple priorities in a fast-paced environment while maintaining high standards for accuracy and follow-through.

**Organizational Effectiveness**

- Serve as the day-to-day project manager for strategic initiatives, coordinating cross-functional work, managing timelines and dependencies, and driving decisions and deliverables to completion.
- Support effective governance by preparing agendas and materials, maintaining decision and action tracking, and coordinating follow-up.
- Identify opportunities to use AI, digital capabilities, and automation to improve analysis, planning, communication, and operational efficiency.

**What We Expect of You**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a collaborative and analytically minded business operator who can manage complex work, communicate clearly, and help cross-functional teams turn priorities into results.

**Basic Qualifications**

- Doctorate degree

OR

- Master's degree and 2 years of operations, consulting, strategy, business analytics, or commercial experience

OR

- Bachelor's degree and 4 years of operations, consulting, strategy, business analytics, or commercial experience

OR

- Associate's degree and 8 years of operations, consulting, strategy, business analytics, or commercial experience

OR

- High school diploma / GED and 10years of operations, consulting, strategy, business analytics, or commercial experience

**Preferred Qualifications**

- Experience in Business Operations, Strategy and Operations, Commercial Excellence, Consulting, Analytics, project management, or a related commercial role.
- Commercial and business acumen, with the ability to connect data and business context to practical recommendations.
- Experience supporting brand planning, business reviews, forecasting, performance management, governance, or strategic initiatives.
- Analytical and structured problem-solving skills, including the ability to turn unstructured business questions into clear work plans.
- Demonstrated project management experience, including ownership of timelines, deliverables, risks, dependencies, and stakeholder alignment.
- Strong written and verbal communication skills, including experience developing and presenting materials for senior leaders.
- Ability to synthesize complex information and communicate the implications clearly to different audiences.
- Proven ability to collaborate across functions, influence without direct authority, and build trusted relationships in a matrixed organization.
- Strong organization and prioritization skills, with careful attention to detail and the ability to manage multiple deadlines.
- Proactive, intellectually curious, and comfortable identifying problems and recommending solutions.
- Interest in applying AI, automation, and digital tools to improve business performance and ways of working.
- Experience in the biopharmaceutical industry, rare disease, or specialty markets is preferred.

**What you can expect of us**

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

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

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

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

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

careers.amgen.com

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

Application deadline

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

Sponsorship

Sponsorship for this role is not guaranteed.

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

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

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

District of Columbia

Principal Manufacturing Systems Engineer

**Join Amgens Mission of Serving Patients**

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

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

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

**Principal Manufacturing Systems Engineer**

**What you will do**

Lets do this. Lets change the world. Does the thought of supporting most technologically advanced manufacturing sites globally excite you? Do you love building and developing high performing teams? If you are passionate and want to be a part of Amgens mission to serve patients every patient. Every time then check out this exciting new opportunity.

In this vital role, you will drive overall program success by applying program and project management principles to teams, partnering with business and technology leaders to ensure comprehensive alignment, and finding optimized ways to deliver efficiency and quality for our partners.

We are seeking a Principal Manufacturing Systems Engineer with solid leadership skills in any of Amgen Manufacturing locations in the US or Europe to join our Ops Technology Manufacturing & Engineering team to help drive productivity through the company using technology to unlock opportunities to stop, optimize processes and then automate as appropriate. Are you someone that has extensive experience on the Operations technology (Aveva Pi, DeltaV, Rockwell, MES) and Program Management to take progressive project management approaches, Are you eager to take your program management, continuous improvement & SAFE-Agile, financial management skills and use them in creative new ways to build groundbreaking Operation smart technologies that helps develop life-changing biotech medicines?, If so, this may be the right place for you.

**Responsibilities:**

Lead large capital project and product teams, by fostering Agile delivery while operating within GMP manufacturing environments.

Partner with site and global stakeholders to prioritize demand, manage backlogs, and balance local needs with global strategy.

Accountable for financials, resource planning, vendor performance, and delivery against scope, schedule, and quality targets.

Drive global standards, templates, and best practices for large operations technology project/product design, deployment, lifecycle management and support to enable scalability and operational excellence.

Ensure solution delivery meet GMP compliance, data integrity, electronic batch records, and regulatory inspection readiness.

Lead cross-functional collaboration between site and corporate Operations, Quality, IT, OT, Automation, Platform Owners and external system integrators

Own the global operations technology roadmap including upgrades, standardization, harmonization, and site deployments, aligned with business and regulatory requirements.

Present status updates and progress to senior leadership at various governance meetings.

**A day in the life:**

You are leading from the front engaging with business functions across the company to help deliver core manufacturing systems.

Partnering with strategy group at Amgen and business partners to deliver initiatives.

Lead a team of PMs, Platform SMEs, Communication resources to ensure structure of how we operate within the program.

Drive financial compliance/adherence of the program via the various projects.

Own overall Program roadmap and communicate program status/milestones to executive leadership.

Ensure product teams operate in the spirit of Agile and have backlogs that are being handled optimally.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The Project manager, Program manager, Product Owner or Scrum Master professional we seek is an Agile methodology authority and traditional waterfall project management methodology with these qualifications.

**Basic Qualifications:**

Doctorate degree and 2 years of Information Systems/Manufacturing Process Automation experience

OR

Masters degree and 4 years of Information Systems/Manufacturing Process Automation experience

OR

Bachelors degree and 6 years of Information Systems/Manufacturing Process Automation experience

OR

Associates degree and 10 years of Information Systems/Manufacturing Process Automation experience

OR

High school diploma / GED and 12 years of Information Systems/Manufacturing Process Automation experience

**Preferred Qualifications:**

Program/project/product management and delivery experience around manufacturing core systems like Aveva Pi, DeltaV, Rockwell, Korber MES, Digital Infrastructure, Advanced digital smart technologies etc.

Solid understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies, 21 CFR Part 11.

Fluent in Agile methodologies with respect to technology solutions and their development and timeline.

Experience as a Product Owner or Scrum Master is preferred.

Manage integration of OT platforms (MES, PI data etc) with core manufacturing and enterprise systems (ERP, LIMS, historians, automation layers such as DeltaV/Rockwell, and data platforms).

Strong written and oral communication skills with scientific domain expertise to communicate effectively with various partners within the organization.

Self-motivated individual with demonstrated ability to learn new concepts and technologies, work multi-functionally in teams (internal and external).

Project Finance experience.

You will have a consultant attitude, with the ability to clarify and control a diverse and shifting program lifecycle. Creativity and flexibility will be key components to excelling in this role.

**What you can expect of us**

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

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

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

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

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

Stock-based long-term incentives

Award-winning time-off plans

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

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

**careers.amgen.com**

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

**Application deadline**

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

**Sponsorship**

Sponsorship for this role is not guaranteed.

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

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

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