Associate Manufacturing - AML6 Drug Substance

Juncos, PR, US
Jul 22, 2019
Required Education
Bachelors Degree
Position Type
Full time
Amgen is looking for creative and hardworking professionals to join AML6-Drug Substance team as Associate Manufacturing. We have multiple positions available within the areas of Cell Culture, Purification, Buffer Prep, Media Prep and/or Component Prep- each aligned to a non-standard work scheduled.

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 onboarding and applicable training qualifications; you will set about preparing and operating operation-critical equipment. And by doing so, developing your experience with 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, 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.

Basic skills and education needed

Bachelor's degree

Beyond that, you will also need:
  • Educational background in Life/Natural Science and/or Engineering
  • Minimal work experience in a manufacturing GMP regulated environment
  • Robust knowledge and proven successful track execution of Good Manufacturing Procedures.
  • Intermediate Mathematics and problem-solving skills.
  • Competent performing assembling disassembling, operating and understanding equipment per procedures.
  • 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.

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.

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.