Manufacturing Associate Jobs at Amgen with Visa Sponsorship
Manufacturing Associate jobs at Amgen sit at the intersection of rigorous science and large-scale biologics production, covering cell culture, purification, fill-finish, and quality operations. Amgen has a well-established sponsorship infrastructure and actively supports international candidates across multiple visa categories for manufacturing functions.
Find Manufacturing Associate Jobs at AmgenOverview
Showing 5 of 10+ Manufacturing Associate Jobs at Amgen
See all Manufacturing Associate Jobs at Amgen
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Manufacturing Associate Jobs at Amgen.
Get Access To All JobsINTRODUCTION
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s 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 FleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleXBatch 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.
ROLE AND RESPONSIBILITIES
In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.
Responsibilities include:
- Manage major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors, internal auditors, and management.
- Clearly communicate investigation progress to impacted areas and leadership.
- Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
- Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
- Build effective relationships across functions.
- Navigate through ambiguity and provide a structured problem-solving approach.
- Apply inductive and deductive reasoning in the investigation process.
- Clear and concise technical writing.
- Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
- Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.
BASIC QUALIFICATIONS
Doctorate degree
Or
Master’s degree & 2 years of directly related experience
Or
Bachelor’s degree & 4 years of directly related experience
Or
Associate’s degree & 8 years of directly related experience
Or
High school diploma / GED & 10 years of directly related experience
PREFERRED QUALIFICATIONS
- 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis®, Design of Experiment etc.), critical thinking, project management, and quality systems.
- Degree in Science or Engineering
- Experience leading complex investigations
- Experience using Veeva QMS for Deviation investigations and CAPAs
- Demonstrated project management ability
- Experience presenting to inspectors during regulatory inspections and internal audits.
- Excellent written and verbal communication skills
- Ability to work in a team matrix environment and build relationships with partners
- Strong interpersonal skills
LOCATION
Location: US - North Carolina - Holly Springs
COMPENSATION
- Salary Range: 107,545.40 USD - 145,502.60 USD
WHAT YOU CAN EXPECT OF US
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.
Join us for a career that defies imagination. Objects in your future are closer than they appear.
INTRODUCTION
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s 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 FleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleXBatch 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.
ROLE AND RESPONSIBILITIES
In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.
Responsibilities include:
- Manage major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors, internal auditors, and management.
- Clearly communicate investigation progress to impacted areas and leadership.
- Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
- Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
- Build effective relationships across functions.
- Navigate through ambiguity and provide a structured problem-solving approach.
- Apply inductive and deductive reasoning in the investigation process.
- Clear and concise technical writing.
- Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
- Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.
BASIC QUALIFICATIONS
Doctorate degree
Or
Master’s degree & 2 years of directly related experience
Or
Bachelor’s degree & 4 years of directly related experience
Or
Associate’s degree & 8 years of directly related experience
Or
High school diploma / GED & 10 years of directly related experience
PREFERRED QUALIFICATIONS
- 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis®, Design of Experiment etc.), critical thinking, project management, and quality systems.
- Degree in Science or Engineering
- Experience leading complex investigations
- Experience using Veeva QMS for Deviation investigations and CAPAs
- Demonstrated project management ability
- Experience presenting to inspectors during regulatory inspections and internal audits.
- Excellent written and verbal communication skills
- Ability to work in a team matrix environment and build relationships with partners
- Strong interpersonal skills
LOCATION
Location: US - North Carolina - Holly Springs
COMPENSATION
- Salary Range: 107,545.40 USD - 145,502.60 USD
WHAT YOU CAN EXPECT OF US
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.
Join us for a career that defies imagination. Objects in your future are closer than they appear.
See all Manufacturing Associate Jobs at Amgen
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Manufacturing Associate Jobs at Amgen.
Get Access To All JobsTips for Finding Manufacturing Associate Jobs at Amgen
Align your credentials to GMP manufacturing standards
Amgen's manufacturing sites operate under strict FDA Good Manufacturing Practice regulations. Before applying, verify your educational background and any prior lab or production experience maps directly to GMP compliance, aseptic technique, or bioprocess operations, since these are the qualifications Amgen screens for first.
Target Amgen sites with active production pipelines
Amgen staffs Manufacturing Associates across sites like Thousand Oaks, West Greenwich, and Juncos. Research which facilities are expanding production for approved biologics or pipeline therapies, as those locations are most likely to have active sponsorship bandwidth for new hires.
Clarify your OPT or CPT timeline before applying
If you're on F-1 status, confirm exactly how many months of OPT remain before your first interview. Amgen's onboarding and training cycle for Manufacturing Associates can run several weeks, so a tight OPT window may complicate your start date and H-1B cap-gap planning.
Understand the LCA filing step before your offer
Before Amgen can file your H-1B or E-3 petition, the company must obtain a certified Labor Condition Application from the DOL confirming prevailing wage compliance for your specific role and work site. Knowing this step exists helps you set realistic timelines when negotiating a start date.
Use Migrate Mate to filter open Manufacturing Associate roles
Roles that include visa sponsorship are not always labeled consistently across job boards. Use Migrate Mate to filter Manufacturing Associate openings at Amgen by sponsorship type, so you're applying only to positions where your visa category is explicitly supported.
Prepare documentation linking your degree to your specific function
For specialty occupation visa categories, USCIS requires a clear connection between your degree field and the Manufacturing Associate duties you'll perform. If your degree is in biochemistry, bioengineering, or a related discipline, gather transcripts and course records that show direct relevance to upstream or downstream manufacturing work.
Frequently Asked Questions
Does Amgen sponsor H-1B visas for Manufacturing Associates?
Yes, Amgen sponsors H-1B visas for Manufacturing Associate roles. The company has an established immigration function that manages petitions across its U.S. manufacturing sites. Because H-1B approval requires demonstrating specialty occupation status, your application materials should clearly connect your degree field to the technical duties of the role, such as bioprocess operations, GMP compliance, or analytical testing.
Which visa types does Amgen commonly sponsor for Manufacturing Associate roles?
Amgen sponsors several visa categories for Manufacturing Associates, including H-1B, E-3 visa for Australian citizens, TN visa for Canadian and Mexican nationals, and Green Card pathways through EB-2 and EB-3 classifications. F-1 OPT and CPT are also supported, making Amgen accessible to recent graduates who need work authorization while transitioning from student status to a long-term visa.
What qualifications does Amgen expect for Manufacturing Associate positions?
Amgen typically looks for a bachelor's degree in biochemistry, chemical engineering, biology, or a related life sciences field. Hands-on experience with GMP environments, bioreactor operations, chromatography, or fill-finish processes strengthens your candidacy significantly. Some roles, particularly at senior associate levels, may expect prior industry experience in biologics or pharmaceutical manufacturing rather than purely academic backgrounds.
How do I apply for Manufacturing Associate jobs at Amgen?
Applications go through Amgen's careers portal, where roles are listed by site and function. To find positions that explicitly include visa sponsorship, use Migrate Mate to filter Manufacturing Associate openings at Amgen by visa type before applying. Tailor your resume to highlight GMP experience, technical skills relevant to the posting, and any prior work in regulated manufacturing environments, since Amgen's screening process is highly role-specific.
How do I plan my timeline if I need H-1B sponsorship from Amgen?
The H-1B cap registration window opens in March each year, with an October 1 start date for selected candidates. If you're on F-1 OPT, your employer can file before your OPT expires and you may be eligible for a cap-gap extension that keeps you authorized while USCIS processes the petition. Coordinate your anticipated start date with Amgen's HR and immigration team early, since the DOL's LCA certification must be completed before the H-1B petition can be filed.