Manufacturing & Production

American Type Culture Collection (ATCC)

Senior Manager, Warehouse and Distribution

Ready to shape the future of science and global health? A global nonprofit that provides trusted biological materials for science and health, **ATCC is hiring Senior Manager, Warehouse and Distribution.**

The Senior Manager, Warehouse and Distribution is responsible for overseeing shipping, receiving, warehouse, and distribution operations onsite in Manassas, VA. This role leads teams responsible for inbound receipts, inventory control, storage, and outbound shipment of biological materials, finished goods, and dangerous goods while ensuring compliance, operational efficiency, material quality, and employee safety. The position collaborates closely with internal stakeholders, international distributors, packaging and freight vendors, and customer-facing partners to support domestic and global distribution activities. The role also contributes to operational planning, performance management, reporting, budgeting, training, and continuous process execution.

**We are seeking a Senior Manager, Warehouse and Distribution, ideally with warehouse, distribution, and logistics leadership experience supporting regulated shipping and receiving operations.** Join ATCC and be part of a team that supports the global scientific community with trusted, authenticated biological materials.

**Responsibilities**

- **Warehouse & Distribution Operations:**  Oversee process of daily receiving, storage, shipping, and distribution activities for materials, finished goods, and dangerous goods.
- **Shipping Execution:**  Implement and maintain outbound shipping processes to support accurate, timely order fulfillment and adherence to packaging and transportation requirements.
- **Compliance & Training:**  Ensure staff training and compliance with USDOT, IATA, and dangerous goods transportation regulations and safety requirements.
- **Inventory & Receiving Control:**  Oversee material receipt, unloading, inventory accountability, and quality verification against organizational standards.
- **Performance & Financial Management:**  Develop and monitor operational metrics, prepare reports, oversee departmental budgets, and investigate expense and shipping variances.
- **Team Leadership & Collaboration:**  Supervise and lead personnel development, performance management, cross-functional collaboration, and issue resolution related to shipping and receiving operations.

**Qualifications**

- Minimum Requirement: Bachelor's degree and 12 years of experience, or equivalent experience (PhD and 5 years, Master's degree and 8 years, or High School Diploma and 16 years).
- Demonstrated supervisory and leadership experience managing warehouse, shipping, receiving, and distribution operations.
- Strong knowledge of inventory control, material handling, inbound receiving, and outbound shipping processes.
- Experience working with ERP systems in a warehouse, logistics, or distribution environment.
- Strong communication and collaboration skills with internal stakeholders, vendors, distributors, and operational partners.
- Experience investigating and resolving shipping, receiving, damage, delay, and discrepancy issues.
- Knowledge of USDOT, IATA, and dangerous goods transportation regulations.
- Experience developing operational metrics, reporting, budgeting, and expense analysis.
- Preferred: Experience supporting cold chain logistics and distribution operations.

**Benefits**

The expected salary range for this position is $120,000 to $135,000 annually. Actual compensation will be determined based on experience and qualifications as well as internal equity and alignment with market data. In addition to base salary, this role may be eligible for additional incentive compensation including regular merit increases and the corporate bonus program.

**We Invest in You**

- **Health & Wellness:**
  - Comprehensive medical coverage and company paid Life Insurance, Disability Insurance, AD&D, and paid parental leave
  - Work life balance with Paid Holidays and PTO
  - Fitness and cell phone subsidies, and additional benefits such as legal services, pet insurance and additional supplemental coverage.
  - Employee Assistance Program offering around-the-clock counseling
- **Financial security:**
  - 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans
  - Exceptional career advancement opportunities, recognition, and rewards
  - Corporate bonus program
- **Mission Focused:**
  - Non-profit organization supporting critical life science research
  - We give scientists the tools they need to make discoveries that improve and save lives
  - Contribute to community involvement and social responsibility

Join ATCC, where we fuel your success, well-being, and development. We're a mission-focused non-profit Equal Opportunity Employer, celebrating a century of supporting global public health. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Shape the future of science with us.

Virginia

Product Operations Specialist

Ready to shape the future of science and global health? A global nonprofit that provides trusted biological materials for science and health, **ATCC is hiring a Product Operations Specialist.**

The Product Operations Specialist drives organizational excellence through data management, process improvement, and project tracking, ensuring portfolio operations consistency, scalability, and cross-functional collaboration. This hybrid role is based in Gaithersburg, MD (or Manassas, VA) and analyzes portfolio, product, commercial, and operational data to support lifecycle decisions, portfolio prioritization, commercialization activities, and business performance across a diverse life sciences product portfolio.

**Seeking Product Operations Specialist, ideally with process improvement, project management or sales operations experience with background in business analytics and product operations.** Join ATCC and be part of a team that supports the global scientific community with trusted, authenticated biological materials.

\#LI-Hybrid

**Responsibilities**

- **Product Data:**  Organize and maintain product master data, portfolio hierarchies, and product information across enterprise systems with meticulous attention to data accuracy, consistency, and change control.
- **Portfolio Analytics:**  Evaluate portfolio, product, commercial, and operational data to identify trends, risks, opportunities, and recommendations supporting product and portfolio decisions.
- **Commercialization Support:**  Facilitate product launch and commercialization activities by tracking requirements, milestones, dependencies, and launch readiness activities.
- **Reporting & Insights:**  Create and maintain clear, well-organized reports, dashboards, and analytical tools that communicate portfolio performance, lifecycle status, commercialization activities, and operational effectiveness to stakeholders.
- **Lifecycle & Governance:**  Support lifecycle tracking, portfolio assessments, governance activities, business reviews, and prioritization discussions through analysis and decision-support materials.
- **Process Improvement & Project Tracking:**  Drive process improvements and track project milestones across cross-functional teams including Product Management, Marketing, Sales, Operations, and Customer Service, maintaining clear communication and organizational accountability throughout the portfolio lifecycle.

**Qualifications**

- Minimum Requirement: Bachelor's degree and 2 years of experience, or equivalent experience (Master's degree and 0 years, or HS Diploma and 6 years).
- Bachelor's degree and 2 years of experience, or equivalent experience (Master's degree and 0 years, or HS Diploma and 6 years) (Minimum Requirement).
- Experience analyzing portfolio, product, commercial, and operational data to identify trends, risks, opportunities, and recommendations.
- Experience maintaining product master data, portfolio hierarchies, and product information across enterprise systems while supporting data integrity and change control activities.
- Strong ability to organize and drive clear, well-structured reports, dashboards, analytical tools, and decision-support materials for portfolio and business performance reviews, demonstrating excellent communication of complex data.
- Preferred: Experience supporting commercialization activities, product launches, launch readiness reviews, and lifecycle management processes.
- Preferred: Experience with project tracking and management, process improvement initiatives, and cross-functional collaboration with demonstrated strong organizational and communication skills within a life sciences environment.

**Benefits**

The expected salary range for this position is $75,000 to $85,000 annually. Actual compensation will be determined based on experience and qualifications as well as internal equity and alignment with market data. In addition to base salary, this role may be eligible for additional incentive compensation including regular merit increases and the corporate bonus program.

**We Invest in You**

- **Health & Wellness:**
  - Comprehensive medical coverage and company paid Life Insurance, Disability Insurance, AD&D, and paid parental leave
  - Work life balance with Paid Holidays and PTO
  - Fitness and cell phone subsidies, and additional benefits such as legal services, pet insurance and additional supplemental coverage.
  - Employee Assistance Program offering around-the-clock counseling
- **Financial security:**
  - 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans
  - Exceptional career advancement opportunities, recognition, and rewards
  - Corporate bonus program
- **Mission Focused:**
  - Non-profit organization supporting critical life science research
  - We give scientists the tools they need to make discoveries that improve and save lives
  - Contribute to community involvement and social responsibility

Join ATCC, where we fuel your success, well-being, and development. We're a mission-focused non-profit Equal Opportunity Employer, celebrating a century of supporting global public health. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Shape the future of science with us.

Maryland

Sanofi US

Plant Process Commissioning Qualification Engineer

**Job Title**: Plant Process Commissioning Qualification Engineer

- Location: Swiftwater, PA

**About the Job**

The Plant Process Commissioning Qualification Engineer is a critical engineering quality review and execution support role responsible for the consistent application governance and maintenance of Commissioning and Qualification Engineering platform procedures In this role you will apply Commissioning and Qualification testing templates engineering standards and specifications across both OPEX and CAPEX projects You will directly support antigen and filling manufacturing operations with a strong emphasis on Inspection and Packaging processes work that ultimately protects patients and ensures the integrity of life saving vaccines and pharmaceutical products.

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**

- Review and approval of SAT FAT Commissioning and Qualification and Design documentation protocols test scripts reports assessments.
- Impact assessments Change Control Functional Component and Design Review Design Qualification DRDQ.
- Protocol and Test Script authoring.
- Continuous improvement authoring updates to site Commissioning and Qualification platform procedures
- Engineering Change Management process
- Contractor management

This role offers a dynamic blend of technical leadership quality governance and cross functional collaboration.

**As a key member of our engineering team, you will**

- Serve as the primary Commissioning and Qualification Engineering interface with project management and project controls functions supporting contractor budget and schedule performance measurements and reporting Provide strong Commissioning and Qualification focus and oversight for packaging and inspection systems.
- Provide Commissioning and Qualification support for projects focusing equipment and utilities to support Drug substance processing Final Filling process and Inspection and Packaging
- Review and approve protocols test scripts data packs and reports to ensure consistent high-quality engineering documentation across all assigned projects.
- Audit engineering quality in accordance with site and project level Commissioning and Qualification plans development qualification Global Engineering Guidelines and Quality Operational Qualification Guidelines.
  Update and approve site Commissioning and Qualification platform methods and procedures ensuring alignment with project lessons learned GEG updates and global quality document revisions.
- Support technical engineering staff in the use and documentation of the engineering change management process.
- Execute audit initiatives and remediation activities including action items resulting from internal and external audits change controls and deviation remediation as directed by the Plant Process and Commissioning and Qualification Lead and or Site Project Engineering Lead
- Manage contract associates as required to support Commissioning and Qualification activities.

**Scope and Impact**

Your work will directly influence the quality and compliance of engineering documentation across both CAPEX and OPEX projects by applying Global Engineering Guidelines and local engineering methods you will ensure that every project meets the highest standards of engineering and regulatory excellence Specific activities include

- Executing System and Functional Component Criticality Assessments
- Conducting Design Review and Qualification activities
- Authoring Protocols Test Scripts and Reports as assigned
- Authoring technical assessments in support of change controls deviations and CAPA

**About You**

**Basic qualifications**

- Bachelors degree in Engineering, Pharmaceutical Sciences, Life Sciences, Biotechnology, Computer sciences or other related technical fields.
- 5+ years of experience in Commissioning, Qualification, Testing Equipment, quality assurance, Engineering, Packaging or other related fields.

**Additional skills:**

- Packaging and Inspection process systems
- Process Equipment Filling systems isolators purification systems
- Chromatography systems autoclaves washers and Controlled Temperature Units
- GMP Utilities WFI Clean Steam Clean Compressed Air
- Experience in the vaccine or pharmaceutical industry
- Demonstrated expertise in the quality review of good documentation practices
- GDP Knowledge of quality and regulatory requirements applicable to pharmaceutical and biotech manufacturing
- Experience with contemporary commissioning and qualification methods

**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 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-SP

\#LI-SP

\#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>)

Pennsylvania

Amgen

Process Development Sr Associate

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. 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**

Duties: Perform method development and qualification studies using High Performance Liquid Chromatography (HPLC), Ultra-High Performance Liquid Chromatography (UHPLC), and Capillary Electrophoresis (CE) platforms; Perform chromatographic fractionation, peptide mapping, intact mass, and other Liquid Chromatography Mass Spectrometry (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; 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; and Perform experiments to help answer questions from health authorities; and Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.

Requirements: Bachelors degree (or foreign equivalent) in Chemistry, Chemical Biology or related field & 2 years of experience in the job offered or a research-related occupation. Position requires 2 years of experience in the following:

- Analytical chemistry experience for protein molecules, and completion of project deliverables including: designing and conducting degradation experiments, extracting and analyzing results via dedicated software: Empower, Chromeleon, and ChemStation;

- Liquid Chromatography principles, including the concepts of stationary and mobile phases, partitioning and separation based on different affinities;

- Analytical method development (chromatography and mass spectrometry), technologies and instrumentation including: High Performance Liquid Chromatography (HPLC), Liquid Chromatography Mass Spectrometry (LC-MS), Solo Variable Pathlength Extension (SoloVPE), and Capillary Electrophoresis (CE);

- Method qualification and transfer for analytical instruments, along with data analysis and statistical evaluation of experimental results;

- Application analytical instrument troubleshooting across different platforms: Waters, Agilent, and Maurice;

- Analytical deliverables for pharmaceutical processes and product development;

- Data analysis, statistical analysis and method qualifications and transfers;

- Technical knowledge of proteins and peptides;

- Implementing Standard Operating Procedures in a laboratory environment in accordance with good laboratory practices (GLP) standards; and

- Recording experimental conditions, results and observations in a laboratory notebook.

Contact: Interested candidates please apply via [https://careers.amgen.com/en/search-jobs](<https://careers.amgen.com/en/search-jobs>) and search for job # R-255469.

Job type: Full-Time position. The annual salary range for this position in the U.S. is $91,125.00 - $108,296.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit[https://careers.amgen.com/life-at-amgen/benefits/](<https://urldefense.proofpoint.com/v2/url?u=https-3A__nam11.safelinks.protection.outlook.com_-3Furl-3Dhttps-253A-252F-252Furldefense.proofpoint.com-252Fv2-252Furl-253Fu-253Dhttps-2D3A-5F-5Fnam11.safelinks.protection.outlook.com-5F-2D3Furl-2D3Dhttps-2D253A-2D252F-2D252Furldefense.proofpoint.com-2D252Fv2-2D252Furl-2D253Fu-2D253Dhttps-2D2D3A-2D5F-2D5Fnam11.safelinks.protection.outlook.com-2D5F-2D2D3Furl-2D2D3Dhttps-2D2D253A-2D2D252F-2D2D252Furldefense.proofpoint.com-2D2D252Fv2-2D2D252Furl-2D2D253Fu-2D2D253Dhttps-2D2D2D3A-2D2D5F-2D2D5Fnam11.safelinks.protection.outlook.com-2D2D5F-2D2D2D3Furl-2D2D2D3Dhttps-2D2D2D253A-2D2D2D252F-2D2D2D252Furldefense.proofpoint.com-2D2D2D252Fv2-2D2D2D252Furl-2D2D2D253Fu-2D2D2D253Dhttps-2D2D2D2D3A-2D2D2D5F-2D2D2D5Fcareers.amgen.com-2D2D2D5Flife-2D2D2D2D2Dat-2D2D2D2D2Damgen-2D2D2D5Fbenefits-2D2D2D5F-2D2D2D2526d-2D2D2D253DDwMGaQ-2D2D2D2526c-2D2D2D253D6HFirGB4LnuU4asVt8kNcMhC5SvBtxbjoaC4-2D2D2D2DrMbhtk-2D2D2D2526r-2D2D2D253DZzsBV9k-2D2D2D2DjttVNN1EvZst0Q-2D2D2D2526m-2D2D2D253DbXelMAn-2D2D2D2DLkr6ITgl-2D2D2D2DOVIwCkmHKYirp3gc83wvPae1SgtYIJYqwI2avmaKPLstizO-2D2D2D2526s-2D2D2D253DkeznBgK-2D2D2D2DF4tRtUWSI5ABybrJF1hszDEySq52Jge-2D2D2D2D2Mk-2D2D2D2526e-2D2D2D253D-2D2D2D26data-2D2D2D3D05-2D2D2D257C01-2D2D2D257Cjen01-2D2D2D2540amgen.com-2D2D2D257C660a28539c1044de1e4108db272cafda-2D2D2D257C4b4266a6136841afad5a59eb634f7ad8-2D2D2D257C0-2D2D2D257C0-2D2D2D257C638146845207554495-2D2D2D257CUnknown-2D2D2D257CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0-2D2D2D253D-2D2D2D257C3000-2D2D2D257C-2D2D2D257C-2D2D2D257C-2D2D2D26sdata-2D2D2D3DcYzBM3rFPl6qL6wF1v5QiaiQBXGj4x6xspFO9HqU9Vg-2D2D2D253D-2D2D2D26reserved-2D2D2D3D0-2D2D2526d-2D2D253DDwMGaQ-2D2D2526c-2D2D253D6HFirGB4LnuU4asVt8kNcMhC5SvBtxbjoaC4-2D2D2DrMbhtk-2D2D2526r-2D2D253DZzsBV9k-2D2D2DjttVNN1EvZst0Q-2D2D2526m-2D2D253DUnLMPhr-2D2D2DEGnpr9XBuHlwWv-2D2D2Dn4T7T8VuRZFDjwpT9dOvwdZKz7drSop9P1WDp591w-2D2D2526s-2D2D253Dc0sqSn-2D2D2DN3CobCiFz89Y-2D2D2Ds8tVcO-2D2D2D8OnDdCGlXU0NbgBc-2D2D2526e-2D2D253D-2D2D26data-2D2D3D05-2D2D257C01-2D2D257Crodneyj-2D2D2540amgen.com-2D2D257>)

What you can expect of us

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

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

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

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

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

- Stock-based long-term incentives

- Award-winning time-off plans

- Flexible work models, including remote and hybrid work arrangements, where possible

Apply now 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.

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.

California

Specialist Manufacturing I

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. 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.

**Specialist Manufacturing I**

Duties: Lead and support planning and execution of key initiatives with cross functional teams at the production floor; Liaison at the floor and with cross function teams to assure program (NPI/PRI) preparation, implementation, sustainment and capture and share lessons learned; Provide and analyzes data to support management evaluation of process performance trends. Provide subject matter expertise for area of responsibility; Own quality records including change control, CAPA, deviations, and deliver to timelines; Support AR5 and AR30 manufacturing organizations in the prioritization and execution of these activities to maximize plant performance and plant capacity; Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements; Support of front-line managers through on the floor presence; Own and author critical standard operating procedures and supporting documentation and training; and Anticipate risk and builds contingencies to help mitigate impact.

Requirements: Masters degree (or foreign equivalent) in Regulatory Affairs and Quality Assurance, Bioengineering, Chemical Engineering or related field & 2 years of experience in the job offered or a manufacturing-related occupation. The position requires 2 years of experience the following:

- Implementing Lean manufacturing to optimize inventory, reduce waste and drive continuous improvement methodologies;

- Applying six sigma principles to lower defect rates for process or raw materials;

- Continuous Improvement and Operation Excellence Tools including: 5S, Fish Bone, Poke Yoke, and Build Standard work;

- Good Manufacturing Practice (GMP) production operations;

- Project management methodology and tools including: Spotfire (Data analytics), MES (PAS-X), PI System (data historian), TrackWise, Veeva, and SAP (ERP);

- Safety programs including Job Safety Risk Assessment, Ergonomic Job Measurement System, and identification of risks;

- Data analysis and control charting; and

- Project management skills including collaborating with cross-functional teams to validate the manufacturing line layout according to equipment and process requirements.

Contact: Interested candidates please apply via [https://careers.amgen.com/en/search-jobs](<https://careers.amgen.com/en/search-jobs>) and search for job # R-255463.

Job type: Full-Time position. The annual salary range for this position in the U.S. is $113,173.00 - $145,503.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit[https://careers.amgen.com/life-at-amgen/benefits/](<https://urldefense.proofpoint.com/v2/url?u=https-3A__nam11.safelinks.protection.outlook.com_-3Furl-3Dhttps-253A-252F-252Furldefense.proofpoint.com-252Fv2-252Furl-253Fu-253Dhttps-2D3A-5F-5Fnam11.safelinks.protection.outlook.com-5F-2D3Furl-2D3Dhttps-2D253A-2D252F-2D252Furldefense.proofpoint.com-2D252Fv2-2D252Furl-2D253Fu-2D253Dhttps-2D2D3A-2D5F-2D5Fnam11.safelinks.protection.outlook.com-2D5F-2D2D3Furl-2D2D3Dhttps-2D2D253A-2D2D252F-2D2D252Furldefense.proofpoint.com-2D2D252Fv2-2D2D252Furl-2D2D253Fu-2D2D253Dhttps-2D2D2D3A-2D2D5F-2D2D5Fnam11.safelinks.protection.outlook.com-2D2D5F-2D2D2D3Furl-2D2D2D3Dhttps-2D2D2D253A-2D2D2D252F-2D2D2D252Furldefense.proofpoint.com-2D2D2D252Fv2-2D2D2D252Furl-2D2D2D253Fu-2D2D2D253Dhttps-2D2D2D2D3A-2D2D2D5F-2D2D2D5Fcareers.amgen.com-2D2D2D5Flife-2D2D2D2D2Dat-2D2D2D2D2Damgen-2D2D2D5Fbenefits-2D2D2D5F-2D2D2D2526d-2D2D2D253DDwMGaQ-2D2D2D2526c-2D2D2D253D6HFirGB4LnuU4asVt8kNcMhC5SvBtxbjoaC4-2D2D2D2DrMbhtk-2D2D2D2526r-2D2D2D253DZzsBV9k-2D2D2D2DjttVNN1EvZst0Q-2D2D2D2526m-2D2D2D253DbXelMAn-2D2D2D2DLkr6ITgl-2D2D2D2DOVIwCkmHKYirp3gc83wvPae1SgtYIJYqwI2avmaKPLstizO-2D2D2D2526s-2D2D2D253DkeznBgK-2D2D2D2DF4tRtUWSI5ABybrJF1hszDEySq52Jge-2D2D2D2D2Mk-2D2D2D2526e-2D2D2D253D-2D2D2D26data-2D2D2D3D05-2D2D2D257C01-2D2D2D257Cjen01-2D2D2D2540amgen.com-2D2D2D257C660a28539c1044de1e4108db272cafda-2D2D2D257C4b4266a6136841afad5a59eb634f7ad8-2D2D2D257C0-2D2D2D257C0-2D2D2D257C638146845207554495-2D2D2D257CUnknown-2D2D2D257CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0-2D2D2D253D-2D2D2D257C3000-2D2D2D257C-2D2D2D257C-2D2D2D257C-2D2D2D26sdata-2D2D2D3DcYzBM3rFPl6qL6wF1v5QiaiQBXGj4x6xspFO9HqU9Vg-2D2D2D253D-2D2D2D26reserved-2D2D2D3D0-2D2D2526d-2D2D253DDwMGaQ-2D2D2526c-2D2D253D6HFirGB4LnuU4asVt8kNcMhC5SvBtxbjoaC4-2D2D2DrMbhtk-2D2D2526r-2D2D253DZzsBV9k-2D2D2DjttVNN1EvZst0Q-2D2D2526m-2D2D253DUnLMPhr-2D2D2DEGnpr9XBuHlwWv-2D2D2Dn4T7T8VuRZFDjwpT9dOvwdZKz7drSop9P1WDp591w-2D2D2526s-2D2D253Dc0sqSn-2D2D2DN3CobCiFz89Y-2D2D2Ds8tVcO-2D2D2D8OnDdCGlXU0NbgBc-2D2D2526e-2D2D253D-2D2D26data-2D2D3D05-2D2D257C01-2D2D257Crodneyj-2D2D2540amgen.com-2D2D257>)

What you can expect of us

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

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

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

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

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

- Stock-based long-term incentives

- Award-winning time-off plans

- Flexible work models, including remote and hybrid work arrangements, where possible

Apply now 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.

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.

Rhode Island

R&D Supplier Quality Manager

Join Amgens Mission of Serving Patients

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

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

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

**R&D Supplier Quality Manager**

**What you will do**

Lets do this. Lets change the world. Amgen is seeking a highly motivated R&D Supplier Quality Manager to support the qualifications, oversight, and continuous improvement of suppliers that contribute to Amgens R&D pipeline and our mission to serve patients.

In this role you will support the operational execution of supplier quality management processes for R&D suppliers under GCP, GLP, and GPvP regulations, including suppliers that provide, host, develop, validate, maintain, or support GxP computerized systems used to support regulated preclinical and clinical activities. Working cross-functionally with stakeholders across Quality, Procurement, R&D, Information Systems, Cybersecurity, Privacy, and business process owners, you will provide hands-on oversight of third-party suppliers to ensure compliance, data integrity, patient safety, risk mitigation, and continuous improvement across the supplier lifecycle.

**Key Responsibilities**

- Conduct risk-based supplier assessments, qualification, audit and lifecycle management, including quality agreements across various R&D service categories.
- Lead or support risk-based qualification and ongoing oversight of suppliers that utilize and/or provide GxP computerized systems, interfaces and devices to support clinical and preclinical activities.
- Assessment and oversight of supplier AI-Enabled GXP computerized systems used to support clinical and preclinical activities ensuring compliance to defined procedural controls, policies and standards .
- Plan, lead, and document risk-based audits of supplier GxP computerized systems and associated quality processes to assess regulatory compliance, validation and lifecycle controls, data integrity, security, and the effectiveness of corrective and preventive actions.
- Assess supplier quality systems and controls for computerized system lifecycle management, including validation, data integrity, security, access management, change and configuration management, incident and problem management, backup, recovery, business continuity, and decommissioning.
- Review risk-appropriate quality and technical requirements in supplier contracts and quality agreements, including validation documentation, audit trails, electronic records and signatures, subcontractor controls, regulatory inspection support, data ownership, data retention, and notification of significant changes or incidents.
- Participate in supplier governance and periodic reviews; evaluate service performance, validation status, changes, deviations, incidents, audit outcomes, emerging risks, and CAPA effectiveness, and escalate material GxP or data integrity concerns.
- Support inspection readiness and regulatory responses related to suppliers computerized systems; partner with system owners and subject-matter experts on supplier risk acceptance, remediation, continuity, transition, and exit decisions.
- Monitor supplier performance, track KPIs, and escalate quality issues when appropriate.
- Coordinate and/or execute supplier audits, manage findings, initiate quality records, and ensure timely CAPA closure.
- Maintain supplier data in quality systems (e.g., Veeva, TrackWise) to ensure accuracy and inspection readiness.
- Engage with suppliers to align requirements, governance and process improvement initiatives.
- Ensure compliance with procedures, perform quality checks, and contribute to continuous improvement.
- Collaborate with internal teams (R&D, Supply Chain, Sourcing, QA) to assist in the development and execution of supplier quality strategies.

**Travel**

- Up to 10% domestic and international travel may be required for supplier engagements and audits.

**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 a collaborative partner with these qualifications

**Basic Qualifications:**

- Doctorate degree OR
- Masters degree and 2 years of Science, Engineering, or experience in a related field OR
- Bachelors degree and 4 years of Science, Engineering, or experience in a related field OR
- Associates degree and 8 years of Science, Engineering, or experience in a related field OR
- High school diploma / GED and 10 years of Science, Engineering, or experience in a related field

**Preferred Qualifications:**

- Masters degree or equivalent in Life Sciences or Engineering.
- Knowledge of GxP, ISO standards, and regulatory expectations for R&D suppliers.
- Experience with supplier quality risk assessment tools and audit practices.
- Working knowledge of computerized system validation and assurance principles, risk-based system lifecycle practices, and applicable expectations for electronic records, electronic signatures, audit trails, and data integrity.
- Experience assessing or overseeing GxP technology suppliers, including software, software-as-a-service, cloud, hosting, infrastructure, implementation, validation, and managed service providers.
- Ability to evaluate supplier audit reports, validation plans and reports, requirements and traceability, testing evidence, security and continuity controls, change records, deviations, CAPAs, and service performance data.
- Experience and proficiency in overseeing AI-enabled GxP systems, including risk assessment, governance, validation, data integrity, and ongoing supplier monitoring.
- Excellent written and verbal communication skills.
- Ability to work effectively in cross-functional teams and in a matrixed environment.
- Strong problem-solving and critical thinking abilities.
- Detail-oriented with a continuous improvement mindset.
- Proactive collaboration and relationship-building skills.
- Ability to manage multiple priorities and deliver results under timelines.

**What you can expect from us**

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

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

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

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

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

**careers.amgen.com**

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

Application deadline

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

Sponsorship

Sponsorship for this role is not guaranteed.

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

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

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

District of Columbia

R&D Supplier Quality Sr Manager

Join Amgens Mission of Serving Patients

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

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

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

**R&D Supplier Quality Senior Manager**

**What you will do**

Lets do this! Lets change the world! R&D Quality has developed a Supplier Quality Oversight capability with the primary objective of delivering a robust, risk-based supplier quality program capable of identifying key leading indicators that predict and prevent critical quality issues.

This role as R&D Supplier Quality Senior Manager will report to R&D Supplier Quality leadership within Precision Medicine, Diagnostics and Supplier Quality (PMDSQ) and will be responsible for the Quality oversight of GxP regulated suppliers and service providers used in the R&D organization, with particular focus on those supporting clinical development activities involving GMP and GDP regulated services This role requires a dedicated professional with a passion for quality management and the ability to identify and execute process improvements, ensuring the highest operational standards.

This role involves establishing and cultivating robust, quality-focused relationships with Amgen suppliers and service providers, contributing risk-based assessments, during supplier evaluation and selection based on applicable regulatory requirements and supplier policies, procedures, and practices, managing related records efficiently and compliantly, and ensuring prompt escalation of high-risk issues to leadership.

A key component of this role will be supporting a cross-functional forum that bridges R&D and Operations to address clinical activities involving GMP/GDP requirements or other situations where responsibilities span GxP or functional boundaries. The Senior Manager will help support risk-based triage, stakeholder engagement, decision-making, escalation, and follow-through when regulatory applicability, supplier qualification requirements, Quality responsibilities, or functional ownership are unclear.

The successful candidate will bring strong practical knowledge and experience in GMP and GDP, complemented by experience within GCP and clinical development, along with strong project management, Quality Risk Management, facilitation, and cross-functional leadership skills.

**Key Areas of Responsibility:**

- Provide risk-based Quality governance and oversight for R&D suppliers, with a focus on hybrid clinical suppliers whose services span GCP, GLP, GPvP, GMP, and GDP-requirements.
- Support and facilitate a cross-functional R&D and Operations forum for clinical quality issues involving GMP/GDP requirements, unclear ownership, or multiple functional stakeholders.
- Coordinate intake and risk-based triage of complex clinical supplier and Quality issues, including identification of applicable requirements, potential Quality and business risks, required subject matter experts, and accountable functions.
- Partner with Quality and business stakeholders to establish fit-for-purpose supplier qualification and oversight strategies when activities cross traditional R&D and Operations boundaries.
- Support the development, negotiation, and maintenance of Quality Agreements and other supplier Quality requirements in collaboration with applicable subject matter experts.
- Collaborate with research and other functions to drive the implementation of continuous improvement initiatives.
- Function as the Quality lead for the execution of quality records related to R&D Supplier management activities
- Define and maintain R&D Supplier Quality KPIs and metrics to identify trends, monitor key signals, and support timely and appropriate action.
- Drive timely escalation, documentation, and continuous improvement for supplier-quality risks, including issues that may affect patient safety, product quality, regulatory compliance, or clinical trial timelines.
- Operate effectively within a global, matrixed organization, coordinating across multiple functions and time zones.

**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:**

- Doctorate degree and 2 years of Quality Management or other relevant experience OR
- Masters degree and 4 years of Quality Management or other relevant experience OR
- Bachelors degree and 6 years of Quality Management or other relevant experience OR
- Associates degree and 10 years of Quality Management or other relevant experience OR
- High school diploma / GED and 12 years of Quality Management or other relevant experience

**Preferred Qualifications:**

- Experience in supplier quality management or oversight.
- Working knowledge of GCP, GLP, GPvP, GMP, and GDP regulations, practices, and trends.
- Experience in clinical supply chain Quality or oversight of other GMP/GDP-regulated services used in clinical development.
- Practical experience applying GMP and/or GDP requirements within a regulated life sciences environment.
- Ability to influence and drive progress across functions where direct reporting relationships or clear ownership may not exist.
- Effective and timely decision making and influencing skills executed in a timely manner
- Strong leadership, negotiation, critical thinking and analytical skills
- Skilled in both written and verbal communication for engaging with individuals at all levels within the organization.
- Ability to employ and implement various tools and systems supporting the supplier quality management processes.
- Excellent project management abilities, including coordination of complex cross-functional initiatives.
- Experience working in a global, matrix organization across multiple time zones.
- Experience supporting supplier quality oversight across a complex, cross-functional, or global operating environment.
- Experience in contract negotiations and relationship building with suppliers and service providers.
- Experience in transactional lean, value stream mapping, and identifying areas of process design and improvement.
- Ability to adapt to changing business needs and effectively navigate areas if ambiguity,
- Willingness and capability to travel up to 15%.

**What you can expect of us**

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

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

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

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

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

**careers.amgen.com**

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

**Application deadline**

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

Sponsorship

Sponsorship for this role is not guaranteed.

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

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

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

Manufacturing Manager Programs Cleaning Validation

**HOW MIGHT YOU DEFY IMAGINATION?**

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

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Manufacturing Manager Programs Cleaning Validation**

**Live**

**What you will do**

Lets do this. Lets change the world. In this vital role the Senior Engineer-Validation will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the sites Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance.

**Responsibilities:**

- Lead a team responsible for implementing and maintaining the facility cleaning validation and sterilizationprogram.

- Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANC

- Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment

- Supply cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports)

- Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met

- Furnish technical assistance and represent validation for regulatory filings, audits, and inspections

- Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems

- Support site/network validation driven continuous improvement initiatives

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seekwill possess these qualifications.

**Basic Qualifications**

Doctorate degree OR

Masters degree and 3 years of Validation or Engineering experienceOR

Bachelors degree and 5 years of Validation or Engineering experience OR

Associates degree and 10 years of Validation or Engineering experience OR

High school diploma/GED and 12 years of Validation or Engineering experience

AND In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications**

- Experience managing staff executing technical skills in a safe and compliant manner.

- Proficient technical writing and presentations skills so as tocollaborate with technical and senior management staff

- Expertise in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility

- Extensive experience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administration

- Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC)

- Knowledge of Regulations Eudralex Annex 15, FDA Title 21 CFR Part 210 and 211, Guidelines ASTM E2500 and ICH Q7

- Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans

**Thrive**

**Some of the vast rewards of working here**

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

- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear

**careers.amgen.com**

**#AmgenNorthCarolina**

Equal Opportunity Statement

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

We will ensure that individuals with disabilities are provided a 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 an accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

North Carolina

Senior Process Engineer - CIP/SIP/Autoclaves

**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. 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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**SeniorProcessEngineer-CIP/SIP/Autoclave**

**What youwill do**

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production.This role will develop domainexpertiseand system ownershipto supportprocessoperations, focusing onCIP, SIP and Autoclave engineering and plant equipment.

Demonstrate technical expertise and provide lifecycle support for CIP skid systems, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and associated automation platforms. The role will support commissioning, qualification, startup readiness, routine manufacturing operations, troubleshooting, requalification and continuous improvement initiatives with a focus on CIP, SIP and autoclave systems.

**Site design, construction, start-up, and operational readiness:**

- Support thedesign andbuildof manufacturingequipmentsystems byaligningdesign reviewprocessesand documentswith site requirements, including equipment design and sizing, architecture and electricaldistribution, and piping and instrumentation diagrams.
- Supportfactoryacceptancetestingworking in partnershipwith global engineeringduringsiteinstallation,including reviewing protocolsandresolving punch list items.
- Work withcapitalproject teamto ensure systems are installed andoperatingsafelyandcomply withpertinent environmental health/safety practice,rulesand regulationsas well as Amgen global engineering requirements.Ensurethat systems are installed per the designrequirements.
- Executeand guidethe commissioning and validationof systemsto ensure their operational capabilityis alignedwithmanufacturing requirements andGMPregulationand on-time project delivery.Supportexecution of engineering and performance qualification runswhile providinghypercaresupport as needed.
- Perform engineering assessmentsfor plant equipment operations,implementing equipment modifications, and supporting engineering runsin support of new product/technology introductions asrequired.

**Site Operations:**

- Responsible system ownerforCIP, SIP and AutoclaveDrug substanceprocess equipment, areas, and systems providingend-to-endsupport for operations.
- Effectively collaborate with key customers and support groups(e.g.Manufacturing, Quality, Process Development, Maintenance, network partners)to ensure reliable plant operations.
- Work with original equipment manufacturers for breakdown and planned maintenance ofprocess equipmentas applicable.
- Leadidentifyingand implementing engineering-based improvements or upgrades toprocessequipmentsystems.This may include developing business cases for improvements,identifyingdesign requirements, and translating these requirements intoprocessequipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
- Developmastermaintenance programsfor equipment, ensure the availability of spare parts, andcoordinate maintenance activities to ensure systems are in proper working order.
- Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for theprocessequipment.
- Providetechnical masteryandproblem-solvingleadershiptoproactivelyreduce production downtime. Thisincludes leadingtechnical root cause analysis and implementation of corrective/preventiveactions for families of systems.
- Leadnew product/technology introductions by performing engineering assessments,equipment performance risk assessments,identifyinggaps and owning their remediation,implementing equipment modifications, and supporting engineering runs.
- Provide rotational on-call support and/or shift support based on business needs to ensure24x7 day-to-dayreliability of Solution Prep, Upstream and Downstream systemsfor plant operations.
- On-site and up to10% domestic/international travel.

**What we expectofyou**

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

**Basic Qualifications:**

- Doctorate degreeOR
- Mastersdegree and 2 years of Engineering experienceOR
- Bachelorsdegree and4years ofEngineeringexperienceOR
- Associatesdegree and8years ofEngineeringexperienceOR
- High school diploma / GED and10years ofEngineeringexperience

**Preferred Qualifications:**

- Degree in Chemical or Mechanical Engineeringor similar engineering discipline.
- 6+years'of relevant work experience with 5+ years' experience in Biopharmaceuticaloperations/manufacturing environment
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Productionfacility equipment/systemswith direct experience withSolution Prep,Upstream,andDownstreampurification equipment suchasweigh and dispense equipment, solution preparation vessels,cell culture reactors, centrifugation, chromatography,viralfiltration skids,andUFDFskidsas well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
- Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
- Experience working in a regulated environment (e.g.cGMP, OSHA, EPA, etc.) andfamiliarity with GMP quality systems/processes such as change control, non-conformances,corrective and preventative actions, and qualifications/validation
- Understanding ofsafety requirements working in a GMP Biopharmaceuticalproductionfacility.
- Independent, ambitious, organized, able to multi-task in project environments, and skilled incommunication, facilitation, and teamwork.
- Strong leadership, technical writing, and communication/presentation skills
- Work schedule flexibility asrequiredto support 24/7 operations.
- Ability for limited domestic/international travel.

Executive Director, Patient Support Operations

**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-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, the Executive Director will set the strategy and direction for Patient Support Operations within Patient Access & Reimbursement (PAR). The role will lead the contact center experience for patients and healthcare professionals (HCPs), advancing the people, processes, technology, automation, and AI capabilities that help customers get the support they need. Reporting to the Associate Vice President of PAR, the Executive Director will lead the teams and partners responsible for patient and HCP contact center activities across the portfolio. This leader will establish a high-performing, scalable operating model that delivers consistent, empathetic service while improving access, efficiency, quality, and customer experience. The Executive Director will work closely with PAR capability leaders, brand teams, Business Technology, Analytics, and external partners to turn customer needs and operational insights into clear priorities and measurable improvements.

**Key Responsibilities:**

- Establish the vision, strategy, and operating model for Patient Support Operations, aligning contact center services with PARs enterprise priorities and the needs of patients, caregivers, and HCPs.
- Lead patient and HCP contact center activities across the portfolio, ensuring a consistent, responsive, and customer-centered experience across channels.
- Set the automation and AI strategy for contact center operations, identifying opportunities to simplify service, expand self-service, improve routing and agent support, and resolve customer needs more effectively.
- Ensure AI and automation solutions are designed around customer needs, integrated with PAR capabilities and technology platforms, and supported by appropriate oversight, quality controls, and performance measures.
- Lead operational planning and performance management, including service levels, access, quality, customer experience, productivity, capacity, and cost.
- Establish clear performance goals and operating reviews; use customer feedback, contact drivers, call analytics, and operational data to identify issues and guide improvement.
- Develop workforce and capacity strategies that align staffing, skills, training, and scheduling with customer demand and portfolio needs.
- Build a strong quality, training, and continuous improvement model that equips teams to resolve customer needs accurately, consistently, and with empathy.
- Partner with Patient Experience leaders, Field Capabilities, Patient Engagement & Affordability, Business Technology, Analytics, and brand teams to align contact center services with patient and HCP journeys.
- Oversee contact center technology and process roadmaps with Business Technology and other partners, translating operational needs into scalable capabilities and ensuring effective implementation and adoption.
- Lead vendor and partner relationships, establishing clear expectations, performance measures, governance, and accountability for service delivery and improvement.
- Ensure operations follow applicable policies, privacy requirements, and compliance standards, with effective controls and escalation processes.
- Represent Patient Support Operations in PAR leadership discussions and cross-functional forums; communicate performance, risks, investment needs, and recommendations clearly.
- Lead, coach, and develop a high-performing leadership team; build a culture of accountability, collaboration, innovation, and continuous improvement.

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. We are all different, yet we all use our unique contributions to serve patients. The Executive Director of Patient Support Operations we seek is an experienced, customer-centered operations leader who can set a clear strategic direction and deliver results at scale. This leader understands how people, process, technology, automation, and AI work together to improve the support experience for patients and HCPs. They can translate operational and customer insights into practical improvements, build strong partnerships across a matrixed organization, and lead teams through change while keeping service quality and customer needs at the center.

The candidate we seek is an experienced leader with the following qualifications. They will also embody the Amgen leadership attributes which are:

- **Inspire:**  Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
- **Accelerate:**  Enable speed that matches the urgency of patient needs by encouraging progress over perfection
- **Integrate:**  Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
- **Adapt:**  Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

**Basic Qualifications:**

- Doctorate degree & 6 years of Marketing experience OR
- Masters degree & 10 years of Marketing experience OR
- Bachelors degree & 12 years of Marketing experience AND
- 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

**Preferred Qualifications:**

- Advanced degree in business, healthcare, operations, technology, or a related field
- Experience leading patient support, healthcare, or customer contact center operations in a complex, regulated environment
- Ability to set strategy and improve service delivery across multiple contact center teams, programs, or portfolios
- Experience developing and implementing automation, AI, digital service, or self-service strategies in customer operations
- Understanding of patient access, reimbursement, healthcare services, and the needs of patients, caregivers, and HCPs
- Experience using customer feedback, call analytics, and operational data to identify service barriers, set priorities, and measure outcomes
- Background in contact center performance management, including service levels, quality, workforce planning, productivity, and customer experience
- Experience leading technology-enabled transformation and partnering with Business Technology, Analytics, and operational teams to implement and sustain change
- Experience managing external vendors and partners through clear governance, service expectations, and performance accountability
- Ability to lead, coach, and develop leaders and teams, and to influence senior stakeholders across a matrixed organization
- Executive communication, strategic thinking, change leadership, and problem-solving skills, including the ability to turn complex operational needs into clear priorities
- Ability to balance customer needs, employee experience, operational performance, compliance, and cost

**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 $258,863 to $ 350,227. 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:

- 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 and bi-annual company-wide shutdowns
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship for this role is not guaranteed.

Florida

Process Development Senior Scientist

**Join Amgens Mission of Serving Patients**

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

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

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

**Process Development Senior Scientist**

**What you will do**

Lets do this. Lets change the world. In this vital role you will serve as part of the Drug Product Team (DPT) providing creative functional area strategies, crafting and executing DOEs during the development of pivotal and commercial ready programs.

This Amgen leader will apply deep expertise in organic molecules and their assemblies to develop innovative, accelerated approaches within cross-functional teams.

Collaborate across DPT and with partner functions, including Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, and Biostatistics.

Build effective working relationships within DPT and across Amgen functions, including Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, and Biostatistics.

Design and execute experiments.

Summarize results in technical documents, regulatory filings, and presentations.

Proactively engage with external industry groups, such as the IQ Consortium, and academic organizations, such as university consortia.

Provide technical expertise on the structure, reactivity, and physicochemical properties of materials, including drug substances and excipients.

**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 go getter with these qualifications.

**Basic Qualifications:**

Doctorate degree

OR

Masters degree and 2 years of **Scientific** experience

OR

Bachelors degree and 4 years of **Scientific** experience

**Preferred Qualifications:**

Ph.D. in a relevant scientific field such as Organic Chemistry, Physical Chemistry, Chemical Engineering, Materials Sciences, or Pharmaceutical Sciences

Strong scientific background for the deep understanding of the organic molecules and their assemblies.

Profound scientific acumen with a focus on organic chemistry, Physical Chemistry, solid-state chemistry, and the physicochemical properties of small molecules.

Industry experience: Prior work in the pharmaceutical sector, particularly with oral solid dosage forms.

Technical proficiency: Familiarity with a wide array of characterization techniques, including but not limited to XRPD, DSC, TGA, and SEM.

Patent process knowledge: Understanding of the patent application process and the legal framework governing patents is advantageous.

Manufacturing insights: Comprehensive knowledge of unit operations involved in producing oral solid dosage forms.

Research leadership: Ability to design, conduct, and complete independent formulation research.

Publication record: Demonstrated history of research dissemination through publications.

Team collaboration: Proven track record of effective cross-functional team engagement.

Writing excellence: Exceptional technical writing capabilities with meticulous attention to detail.

**What you can expect from us**

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

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

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

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

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

**careers.amgen.com**

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

**Application deadline**

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

**Sponsorship**

Sponsorship for this role is not guaranteed.

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

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

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

Process Development Associate

**Join Amgens Mission of Serving Patients**

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

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

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

**Process Development Associate**

**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), antibodydrug conjugates, live oncolytic viruses, and synthetic medicines.

As a PD Associate, the candidate will participate in protein characterization studies to support regulatory filings using Capillary Electrophoresis (CE), 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 CE 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.

**Application deadline**

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

**Sponsorship**

Sponsorship for this role is not guaranteed.

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

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

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

Manufacturing Programs Senior Manager: Cleaning Validation

**HOW MIGHT YOU DEFY IMAGINATION?**

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

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Manufacturing Programs Senior Manager: Cleaning Validation**

**Live**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be part of ANCs Manufacturing Support team, and lead cleaning validation teams for both the existing Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and the new Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This requires managing cleaning validation teams supporting manufacturing plants in different lifecycle phases. It is a highly visible role across the site with the key responsibilities of working cross-functionally to ensure compliance of cleaning validation program to regulatory expectations, driving continual improvement, and maintaining alignment to network lessons learned and best practices. This role will also offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved productivity.

Responsibilities:

- Cross-functional collaboration to ensure on-time delivery of cleaning validation deliverables.

- Provides team oversight, ensuring outputs meet quality and regulatory expectations.

- Support Manufacturing in troubleshooting, problem-solving and RCAs. Support CAPA development to prevent error recurrence.

- Establishes Cleaning Validation Program standard work and best practices, ensuring network alignment and incorporation of lessons learned. Accountable for inspection readiness strategy and development of inspection readiness tools, standard work, and staff training.

- Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant, and tracks progress on a plant level.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics DS manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.

**Basic Qualifications:**

- Doctorate degree in chemistry, biology or engineering & 2 years of biotechnology operations experience or

- Masters degree in chemistry, biology or engineering & 6years of biotechnology operations experience or

- Bachelors degree and 8years of biotechnology operations experience or

- Associates degree & 10 years of biotechnology operations experience or

- High school diploma / GED & 12 years of biotechnology operations experience

- AND In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

**Preferred Qualifications:**

- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.

- Excellent cross-functional project management, meeting facilitation, and technical writing skills.

- Experience in GMP manufacturing operations.

- Strong technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing.

- Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

- Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms.

- Ability to coach, mentor and/or cross train colleagues within core technical areas.

- Background in lean manufacturing methodologies and operational excellence.

**Thrive**

**What you can expect of us**

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

The annual base salary range for this opportunity in the U.S. is provided below.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

- 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 and bi-annual company-wide shutdowns.

- Flexible work models, including remote work arrangements, where possible.

**Apply now**

**for a career that defies imagination**

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

**careers.amgen.com**

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

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

**#AmgenNorthCarolina**

Sr Associate IS Analyst - Process Development Labs

**Join Amgens Mission of Serving Patients**

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

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

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

Sr Associate IS Analyst - Process Development Labs

**What you will do**

Lets do this. Lets change the world. In this vital role you will help create a reliable, secure technology environment for the scientists advancing our medicines. Based at Amgens Thousand Oaks, California facility, youll support the laboratory systems and instrument-connected computers scientists rely on every day. Youll partner with researchers and teams across IT to deploy and maintain lab technology, resolve user needs, keep systems current, and support data protection, backup, and archiving. Youll also help build and maintain tools and automation scripts that make the teams work more efficient. The role offers hands-on experience across lab technology, infrastructure, networking, and databasesand the opportunity to shape solutions that balance scientific needs, security, and enterprise priorities.

Youll join the Benchtop Product Team and support the full lifecycle of laboratory benchtop platforms across Operationsfrom software and hardware refreshes to ongoing system availability. Your work will help scientists stay focused on their research with dependable, up-to-date tools.

**Roles & Responsibilities**

- Partner with the Benchtop Product Team to manage the lifecycle of instrument controller software and laboratory computing platforms.
- Work with scientists and IS colleagues to resolve support requests involving laboratory computers, software and Windows upgrades, and system troubleshooting.
- Coordinate with vendors to obtain current controller software, drivers, patches, and other software packages.
- Collaborate with Amgen infrastructure teams to build and support DEV, TEST, and PROD environments in cloud and on-premises settings.
- Test software and hardware updates, develop migration strategies, and support the benchtop platforms in scope.
- Create and maintain documentation and standard operating procedures for lifecycle processes.
- Manage ServiceNow activities, including Service Access Reviews, application CI records, ISA/TPRA, end-of-life servers, and orphaned assets.
- Work with business partners to develop practical, innovative solutions to day-to-day challenges.

**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 Sr Associate IS Analyst with these qualifications.

**Basic Qualifications**

- Doctorate degree and 2 years of experience in Infrastructure, IT, or a related field; **or**
- Masters degree and 810 years of relevant experience; **or**
- Bachelors degree and 1014 years of relevant experience; **or**
- Diploma and 1418 years of relevant experience.

**Functional Skills**

**Required**

- 35 years of experience in systems administration and infrastructure.
- Strong customer focus and the ability to manage support requests in line with user expectations.
- Experience with networking, DNS, firewalls, security, patching, AWS, and VMware.
- A thorough understanding of Windows and Linux operating systems.
- Ability to define infrastructure requirements for different server types and assess vendor recommendations against business needs.
- Experience developing and maintaining scripts to automate server tasks.
- Proven leadership and organizational skills, including the ability to manage multiple software and hardware lifecycle projects.
- Ability to work with vendors and colleagues to troubleshoot issues, test software versions, and develop lasting solutions.

**Preferred Qualifications:**

- Ability to work independently, solve problems, and communicate professionally in writing.
- Experience with Smartsheet, Excel, or Tableau.
- Experience using generative AI tools such as ChatGPT or Copilot, and familiarity with large language models such as Llama.
- Experience working with business partners to shape and deliver solutions.

**Ways of Working**

- Experience leading technology transformation and managing change.
- Ability to collaborate effectively with global, distributed teams.
- Strong analytical, troubleshooting, and communication skills.
- Ability to manage competing priorities and take initiative.
- Confidence presenting information and speaking to groups.

**What you can expect of us**

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

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

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

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

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

**careers.amgen.com**

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

**Application deadline**

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

**Sponsorship**

Sponsorship for this role is not guaranteed.

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

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

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

Manager Manufacturing, New Product Introduction - Downstream

**HOW MIGHT YOU DEFY IMAGINATION?**

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Manager Manufacturing, New Product Introduction- Downstream**

Live

**What you will do**

Lets do this. Lets change the world. In this vital role you will act as the Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply. This position is within Amgen North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support organization.

ANC is a dynamic environment and an important supply facility for Amgens pipeline products. The GMP DSS plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. This NPI team is a key communication and technical interface between the GMP manufacturing operations teams in the plant and Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality.

- Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant. Includes hiring, training, oversight, performance evaluations, and development.

- Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs (ex. resources, platform technical understanding, cross-functional alignment).

- Lead team meetings and drive alignment in business processes across the team.

- Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality as well as Manufacturing for the introduction of new products, process changes and improvements and/or advanced technologies into the plant.

- Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.

- Collaborate with Regulatory and Quality partners to ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings.

- Drive a culture of inspection readiness across the team by ensuring NPI change controls are kept up to date and supporting staff with audit or regulatory response strategy.

- Interacts with management in planning, developing, and maintaining budget

- Assist in developing and maintaining department goals

- Interact with regulatory agencies as needed

- Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement

- Responsible for selection, training, evaluation, staff relations and staff development

- Mentor and coach staff members to live by the Amgen Values

- Develop and implement trainings plans and programs, to ensure staff are prepared and compliant

- Other functional responsibilities may be assigned

Win

**What we expect of you**

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

**Basic Qualifications:**

- Doctorate degree OR

- Master's degree and3years of biotechnology or pharmaceutical manufacturing experience OR

- Bachelor's degree and5years of biotechnology or pharmaceutical manufacturing experience OR

- Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR

- High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing experience

- In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leadingteams, projects,programs, or directing the allocationorresources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

- Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry

- Experience leading/managing a team of direct reports

- Experience with PAS X, Werum software

- Experience in GMP operations, including New Product Introduction (NPI)

- Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing

- Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

- Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms

- Ability to coach, mentor and/or cross train colleagues within core technical areas

- Background in lean manufacturing methodologies and operational excellence

- Experience in cross functional Project Management

Thrive

**What you can expect of us**

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

Amgen offers a Total Rewards Plan comprising 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 including:

- 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 and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

Apply now

**for a career that defies imagination**

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

careers.amgen.com

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

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

Associate Manufacturing - Bulk Drug Substance Downstream - Days

**HOW MIGHT YOU DEFY IMAGINATION?**

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

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Associate Manufacturing - Bulk Drug Substance Downstream - Days**

**What you will do**

Lets do this! Lets change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup.

Thisessentialrole will be part of a team responsible for manufacturingdownstream purification operations including column packing,columnchromatography, TFF,viralfiltration,viralinactivation, conjugation, and final fill,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility.

This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm. As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, this role must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our operations.

During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steady state operations, the role will shift toward routine manufacturing execution and continuous improvement.

With general direction, the Associate will support all floor operations in accordance with cGMP practices.

**Key Responsibilities:**

**Compliance & Quality**

- Execute work in accordance with established cGMP procedures and policies, including SOPs, MPs, JHAs, and applicable CFRs

- Ensure proper gowning and aseptic techniques are consistently followed

- Initiate and document manufacturing related deviations and quality events as trained

- Support investigations and corrective actions under guidance

- Maintain a strong culture of safety, quality, and compliance

**Operational Readiness & Facility Startup**

- Support operational readiness and facility startup activities as part of the expansion program

- Participate in training, equipment familiarization, and procedure execution to enable startup

- Execute assigned readiness tasks supporting commissioning, qualification, and early manufacturing operations

- Follow defined workflows and procedures to support safe and compliant startup activities

- Provide operational feedback and escalate issues observed during startup execution

**Manufacturing Operations**

- Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and assigned areas

- Run and monitor critical process tasks per approved procedures

- Perform in process sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs)

- Complete washroom activities for small to largescale manufacturing equipment

- Identify and escalate operational issues impacting safety, quality, or schedule

- Maintain an organized, clean, and compliant manufacturing environment

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.

**Basic Qualifications:**

- High School/GED + 2 years manufacturing and/or other regulated environment experience

Or

- Associates Degree + 6 months manufacturing and/or other regulated environment experience

Or

- Bachelors Degree

**Preferred Qualifications:**

- Completion of NC BioWorks Certification Program

- Experience in a regulated industry such as biotechnology or pharmaceutical

- Basic understanding and process experience in a cGMP manufacturing facility

- Strong verbal and written communication

- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

- An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

- Ability to work effectively in a team-based manufacturing environment

**Thrive**

**What you can expect of us**

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

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.

Amgen offers a Total Rewards Plan comprising 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 including:

- 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 and bi-annual company-wide shutdowns

- Flexible work models, including remote work arrangements, where possible

Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

**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. 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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

**Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days**

**What you will do**

Letsdo this!Letschange the world! In this dynamic role, you will be a Sr Associate in the manufacturing organization at Amgen North Carolina (ANC).The essential position, which supports our critical 24/7 manufacturing operations,worksa 12-hour 2-2-3 schedule from 5:45am to 6:15pm.Associates will be executing operations on the floor in our upstreamareaandwillberesponsible forthe manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.

With general direction, the Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.

**Compliance:**

- Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures \[SOPs\], Manufacturing Procedures \[MPs\], Job Hazard Analysis \[JHAs\], Code of Federal Regulations \[CFR\]) with strict adherence to safety and compliance

- Initiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observations

- Interact with regulatory agencies as needed and guided

- Assure proper gowning and aseptic techniques are always followed

**Process/Equipment/Facilities:**

- Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of assigned area

- Run and monitor critical process tasks per assigned procedures

- Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records \[EBR\])

- Complete washroom activities: cleaning equipment, small to large scale, used in production activities

- Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions

- Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs)

- Collaborate cross-functionally (i.e., QA/QC, F&E (Facilities & Engineering), PPIC (Production Planning and Inventory Control), Mfg., PD (Process Development), Regulatory, etc.) in completing production activities

- Responsible for recognizing and elevating problems during daily operations

- Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement

- Drive safety in all operations, and assist the manager in escalating concerns as needed

- Maintain an organized, clean, and workable space

**Administrative:**

- Draft and revise documents (SOPs, technical reports, and MPs)

- Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a team player with these qualifications.

**Basic Qualifications:**

- High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR

- Associates Degree + 2 years manufacturing and/or other regulated environment experience OR

- Bachelors Degree + 6 months manufacturing and/or other regulated environment experience OR
- Master's Degree

**Preferred Qualifications:**

- Completion of NC BioWork Certificate Program

- Experience in biotechnology or pharmaceutical plant start up

- Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment

- Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)

- Excellent verbal and written communication (technical) skills

- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

**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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Sr Associate Digital Manufacturing (12hr PM)

**Join Amgens Mission of Serving Patients**

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

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

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

Sr Associate Digital Manufacturing

**What you will do**

Lets do this. Lets change the world. In this role you will lead various smart manufacturing technology and computerized systems initiatives within manufacturing to support the end user on the shop floor (e.g. AR/VR Technology, MES, ERP, SCADA, Systech, Serialization). You will manage critical processes, provide technical leadership, and be accountable for designing, implementation, and validation of key business systems and digital technologies. You will support the development of master batch records, technical reports, and other Good Manufacturing Practices (GMP) documents that supports smart manufacturing technology and the production process. This role is essential for Amgen Ohios success and key in supporting operations towards the digital future of tomorrow.

**Responsibilities may include, but are not limited to:**

- Provides technical support, project management, and problem solving assistance of various smart manufacturing technology and computerized systems within the manufacturing area.
- Department lead of smart manufacturing technology, computerized systems, and Manufacturing Execution System (MES) and represent site on global network initiatives.
- Support Amgen Ohio digital manufacturing team to trouble shoot and develop new ways of working.
- Act as manufacturing business representative in multi-functional meetings and support all levels of the organization to drive digital manufacturing projects.
- First line Subject Matter Expert (SME) for smart manufacturing technology, computerized systems, MES and ERP.
- Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design, improvements, system configuration, validation, and investigations.
- Support key business system lifecycle management and represent team during system upgrades, improvement and maintenance projects.
- Generate, and review documents (SOPs, FORMs, FMEAs, Deviations, CAPA, CC, etc.) associated and owned by digital manufacturing team.
- Work with team to ensure training on new or revised digital manufacturing processes is effective and completed for end-users.(Operators/Supervisors/Technical/QA/Support Staff).
- Actively assist during trouble shoot and apply problem solving skills.
- Uses the latest data analytics tools and methodologies to tackle systematic problems and improve process efficiencies to maintain production schedule alignment.
- Ensure all actions and responsibilities are completed on time and current schedule is maintained, accurate, and up to date, including proactive communication regarding scheduling challenges and provide possible solutions.

**What we expect of you**

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

**Basic Qualifications:**

High School/GED and 4 years of Manufacturing, Engineering or Computer Science experience.

**Or**

Associates Degree and 2 years of Manufacturing, Engineering or Computer Science experience.

**Or**

Bachelors Degree and 6 months of Manufacturing, Engineering or Computer Science experience.

**Or**

Masters Degree

**Preferred Qualifications:**

- Educational Background or experience in Science, Pharmaceuticals, Biotechnology, Digital Technology, and/or Engineering.
- Experience with design, configuration, qualification/validation in smart manufacturing and computerized systems and system integration supporting manufacturing and the end user on the shop floor (e.g. MES, ERP, SCADA, Systech, Serialization).
- Experience in a GMP environment and background in smart manufacturing technologies and computerized systems and comprehensive understanding of the Manufacturing process with the ability to translate to a System requirements for the end user (ERP and MES).
- Experience in deviations, investigations, root cause analysis, CAPAs and change controls.
- Analytical fact-based problem solver and strong trouble shooting skills on process, equipment, smart technology, and computerized systems.
- Ability to maintain an environment of operation excellence, continuous improvement, and lean manufacturing (Kaizen process improvements).
- The ability/experience working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able adapt quickly to the demands of commercial manufacturing operations.
- Pro-active, result oriented, and ability to prioritize work to meet timelines.
- Good documentation practices and skills including technical writing
- Good communication to all levels of the organization.

**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.

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.

**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.

Ohio

Manufacturing Process Technician -Material Management -Material Handler

**Join Amgen's Mission of Serving Patients**

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas - Oncology, Inflammation, General Medicine, and Rare Disease - we reach millions of patients each year. As a member of the Amgen team, you'll 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and sustainability innovations designed to reduce carbon and waste.

**Manufacturing Process Technician -Material Management -Material Handler**

**Live**

**What you will do**

Lets do this! Lets change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45am to 6:15pm. In this role, you will support manufacturing operations by picking, delivering, and stocking cGMP materials and general consumables in accordance with standard operating procedures within a cGMP environment.

With specific instruction and under supervision, the Material Handler performs hands-on material movement and inventory activities while maintaining strict safety, compliance, documentation, and customer-service standards. The Material Handler will support all floor operations in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shifts, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.

**Responsibilities will include...**

**Safety / Compliance**

- Pick, deliver, and stock cGMP floor-stock materials and general consumables.

- Perform work in accordance with established standard operating procedures (SOPs), cGMP requirements, applicable Code of Federal Regulations (CFR), Amgen policies, and OSHA regulations.

- Maintain compliant training records and follow proper gowning requirements.

- Maintain a clean and safe work area.

- Report safety hazards immediately to leadership.

**Systems**

- Use inventory systems to complete routine transactions and resolve basic system issues within Amgen enterprise resource planning systems, including SAP and MES.

- Use quality, operations, and logistics software applications with appropriate read and write access.

- Review and verify cGMP transactions.

- Manage inventory by removing expired materials from cGMP areas and completing the appropriate MES and SAP transactions.

**Equipment**

- Use powered industrial vehicles (PIVs) to move warehouse materials.

- Conduct pre-operational safety inspections of PIVs.

- May operate trucks to move warehouse materials, hazardous materials, or general consumables.

- Operate warehouse equipment as assigned, including forklifts, pallet jacks, special-purpose cryogenic equipment, and potent-compound equipment.

**Collaboration and Work Practices**

- Interact constructively with peers and internal clients.

- Provide basic customer service and prioritize work to meet deadlines.

- Work effectively in a fast-paced team environment, both independently and as part of a team.

- Perform other functions as assigned.

**Win**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The dependable professionals we seek are team players with these qualifications.

**Basic Qualifications:**

- High school diploma / GED + 1 year of manufacturing and/or other regulated experience

- Or

- Associates degree

**Preferred Qualifications**

- Experience working in a cGMP environment.

- Experience with SAP, MES, inventory systems, or related quality, operations, and logistics software.

- Experience safely operating trucks, vans, powered industrial vehicles, forklifts, pallet jacks, or other warehouse equipment.

- Experience safely handling, transporting, and managing hazardous materials.

- Keen attention to detail and the ability to accurately follow complex written procedures.

- Ability to assemble, disassemble, operate, and understand complex equipment or processes in accordance with procedures.

- Strong computer skills and the ability to work efficiently across multiple software applications.

- Intermediate mathematical skills.

- Good written and verbal communication skills.

- Good problem-solving skills and the ability to prioritize work to meet deadlines.

- Ability to understand and adhere to cGMP requirements.

- Demonstrated alignment with Amgen values.

**Physical Requirements**

- Stand, walk, or move throughout offices, work sites, and Amgen buildings.

- Climb, crawl, crouch, or work in other non-seated positions.

- Lift, carry, push, or pull heavy objects using appropriate industrial equipment.

- Maintain the visual and mental concentration needed to work with specialized equipment and instruments.

**Thrive**

**What you can expect of us**

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

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 relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work/life balance, and career-development opportunities including:

- Comprehensive employee benefits package, including a Retirement and Savings Plan with 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 and bi-annual company-wide shutdowns.

- Flexible work models, including remote work arrangements, where possible.

**Apply now**

**for a career that defies imagination**

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

Manufacturing Process Tech - Solution Prep (Nights)

**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.

**Manufacturing Process Technician - Solution Prep (Nights)**

**What you will do**

Lets do this! Lets change the world! In this vital role you will routinely perform simple to moderately complex processes according to Standard Operating Procedure and Batch Records. Generally, this will include all aspects associated with bulk manufacturing in aseptic and non-aseptic environments.

Responsibilities:

- Equipment and parts cleaning using manual and automated methods and equipment
- Set up and breakdown of single use materials
- Weigh and dispense of raw materials
- Operation and process monitoring of clean systems, autoclaves, and processing equipment
- Sample collection, processing, storage and delivery
- Product and component reconciliation
- Solution preparation and transfer
- Materials handling, weighing and dispensing, power industrial vehicle operation
- Strict adherence to current Good Manufacturing Practices (cGMP's), responsible to accurately complete process-associated documentation, make calculations and perform the physical tasks associated with bulk manufacturing and other duties as assigned.

You will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7am-7pm with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off as well as **receiving an added 15% shift differential.** The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).

**What we expect of you**

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

**Basic Qualifications:**

- High school/GED + 1 year of Manufacturing or Operations work or military experience OR
- Associate's degree

**Preferred Qualifications:**

- Experience in a GMP/ other regulated environment.
- Demonstrated knowledge of GMP principles.
- Drug substance manufacturing experience.
- Ability to stand or sit for extended periods of time.
- Ability to maintain focus during repetitious tasks over the course of a shift.
- Ability to assemble, disassemble, operate and understand simple to moderately complex equipment per procedures.
- Basic understanding of measurements, calculations and the metric system.
- Ability to work effectively in an individual and team setting.
- Ability to document process tasks in electronic batch records.
- Coachable, ability to take coaching/critique and show learned/measurable improvement.
- Capacity to follow written procedures, recognize and report malfunctions.
- Strong communication skills.
- Ability to perform assignments with a high degree of focus/attention to detail.

**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.