Associate Manufacturing

Juncos, PR, US
Jan 09, 2021
Required Education
Bachelors Degree
Position Type
Full time
Amgen is looking for multiple creative and hardworking professionals to join AML7-Drug Substance team as Associate Manufacturing to work non-standard shifts. The AML-7 Facility is the home of outstanding, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, sophisticated equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best drug substance manufacturing facility in the world.

The role:

This is an outstanding opportunity to seek a variety of challenges and responsibilities around our state-of-the-art Microbial facility. The team focuses on a range of readiness, setup, manufacturing processing and analytical testing duties. There will also be opportunities to seek Fermentation and Purification activities. This role also involves monitoring, sampling and testing, use pumps and sterile tube welders and aseptic connectors, documentation of procedures and results.

Specific responsibilities include but are not limited to:
  • Support non-standard shifts organization (first, second, third, twelve hours and/or weekend shifts), as per business needs
  • Hands-on operations, set-up, clean in place, sterilize in place and execute cell culture operations or media preparation per procedures
  • Prepare sampling equipment, analyze samples using sophisticated analytical equipment
  • Perform and supervise critical processes
  • Execute routine validation protocols
  • Follow GMP's in alignment with the compliance of the process
  • Regularly draft and revise "routine" documents (e.g. MPs, SOP's, and technical reports)
  • Initiate Quality incidents
  • Identify and recommend improvements related to routine functions and implement after approval
  • Basic troubleshooting
  • Recognize & accurately report problems
  • Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
  • Interact directly with the Quality Unit
  • May train staff to perform hands-on tasks, act as safety representative, assist with system ownership responsibilities and interact with Process Development and Process Owner teams
  • Understand the big picture to be able to develop deviation documents, and craft more efficient methods and processes around the facility

Basic qualifications:

Bachelor's degree

Preferred qualifications:
  • 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.
  • Proficient 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).
  • 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.

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.

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.

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.