8 days old

Senior Associate Manufacturing - AML6 Media Preparation

Juncos, Puerto Rico 00777
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Job ID: R-104131
Location: Juncos, PR, US 00777

Amgen is looking for a creative and hardworking professionals to join AML6-Drug Substance-Upstream team as Senior Associate Manufacturing.

The role:

This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture facility. After the completion of the on-boarding and applicable training qualifications; you will set about preparing and operating operation-critical equipment. And by doing so, developing your experience with some or all following processes: bioreactors, chromatography & filtration skids, buffer/media preparation, autoclave and part washer systems.

To keep everything running smoothly, you will also be involved in monitoring, sampling and testing, execute physical work, use pumps, sterile tube welders and aseptic connectors - and document procedures and results. Plus, your deep understanding of the big picture will be vital as you help to develop deviation documents, and craft ever-more efficient methods and processes around the facility.

The department:

The AML-6 Facility is the home of best-in-class, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian Drug Substance manufacturing facility in the world.

As part of a non-standard shift, the team focuses on a range of readiness, setup, manufacturing processing and analytical testing duties. With both formal learning and on the job training, it is the perfect place to develop.

Time spent in a classified room performing and monitoring critical processes or executing testing on the floor such as pH, conductivity; hands on experience with SAP, EBR and Equipment Interphase (HMIs) systems and equipment preparations (CIP/PT/SP) would help. But if you are driven, enjoy taking on new challenges, love to work in teams and are a confident communicator, you will thrive here.

Specific responsibilities include but are not limited to:

  • Support non-standard shift manufacturing operations that may include weekends and night shifts.
  • Revise, adherence and provide update to the schedule operations
  • Perform initial review manufacturing procedures/batch records
  • Train Associates Manufacturing on process theory and equipment operation
  • Draft and revise more complex documents (e.g. MPs, SOPs, technical reports, validation documents, investigation reports, etc.)
  • Audit critical records
  • Propose corrective action for Quality incidents
  • Assist, & plan improvement implementation related to routine functions
  • Interact with other departments to implement planned improvements
  • Identify and propose solutions to complex problems.
  • Perform data analysis (e.g., SPC, CPV) of critical process parameters
  • Lead capacity for equipment/process operations
  • Initiate/Close Quality and Safety incidents
  • Identify and recommend improvements related to routine functions and implement after approval.
  • Advanced troubleshooting.
  • Recognize & accurately report problems
  • Direct operators on critical processes
  • May assist with recruiting effort, supervise staff, system owner responsibilities (i.e., process, document) and/or interact with Process Development (other functional areas)
  • Work directly with functional teams to implements improvements and initiatives.

Basic skills and education needed

Master's degree


Bachelor's degree & 2 years of Manufacturing experience in GMP regulated industry

Beyond that, the preferred qualifications are:

  • Educational background in Life/Natural Science and/or Engineering
  • 2+ yrs of work experience in a manufacturing GMP regulated environment
  • 5+ yrs of GMP regulated manufacturing work experience if educational background is from other fields
  • Robust knowledge and proven successful track execution of Good Manufacturing Procedures.
  • Experience leading teams or business projects/initiatives.
  • Intermediate Mathematics and problem-solving skills.
  • Proficient performing assembling disassembling, operating and understanding equipment per procedures. Mechanical ability/expertise
  • Knowledge with basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).
  • Ability and willingness to work any shift in support of operations that may include 24/7.
  • Organization skills and talent to perform assignments with a high degree of attention to detail.
  • Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment.
  • Good documentation skills. Written and oral communication skills in English and Spanish.
  • Understand equipment/processes which leads to greater independent judgment
  • Basic statistical mathematical skills
  • Technical writing capability
  • Understand analytical methods for manufacturing area
  • Basic project management skills
  • Exhibits Amgen's values.

The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

Posted: 2020-09-12 Expires: 2020-10-14

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Senior Associate Manufacturing - AML6 Media Preparation

Juncos, Puerto Rico 00777

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