Amgen

Scientist - Commercial Attribute Sciences

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Oct 16, 2020
Ref
R-106003
Required Education
Bachelors Degree
Position Type
Full time
Amgen is now hiring a Process Development Scientist - Commercial Attribute Sciences for our Thousand Oaks, CA facility.

Amgen discovers, develops and delivers innovative human therapeutics. As a biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives!

As our Process Development Scientist, ASTL (Attribute Sciences Team Lead), you will be a member of our Commercial Attribute Sciences group where you will:
  • Responsible for analytical leadership of a commercial program(s) including method lifecycle management, method transfer, validation and remediation.
  • Support global regulatory filings by authoring analytical CMC sections and RTQs ensuring success of commercial approval and launch
  • Represent Attribute Sciences as a core member of Product Delivery Team(s)
  • Provide analytical subject matter authority technical support to commercial testing, stability programs and manufacturing operations.
  • Interact and collaborate with global cross-functional team that includes DS and DP operations, Quality, Regulatory CMC, Supply Chain and also likely contract manufacturing and testing sites.
  • As ASTL, will integrate and utilize platform and prior product knowledge to advance Amgen practices and ensure success of our commercial portfolio.

Basic Qualifications:

Bachelor's degree and 6 years of Scientific or Operations experience
or

Master's degree and 4 years of Scientific or Operations experience
or

Doctorate degree

Preferred Qualifications:
  • Scientist with 5+ years of experience in providing and driving analytical deliverables for biopharmaceutical processes and product development.
  • Deep understanding of product quality attributes control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product.
  • Commanding knowledge of analytical methods/technologies used in biologics for both routine and characterization testing using HPLC, CE, LC/MS, ELISA, and/or other techniques.
  • Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing.
  • Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.
  • Understanding of biopharmaceutical manufacturing processes.
  • Experience working in a matrix environment.
  • Experience in technical transfer for GMP production and testing to external contract organizations, able to handle results against timelines.
  • Experience in data analysis, statistical analysis, setting acceptance criteria, comparability studies, and process/method transfers.
  • Experience in applying troubleshooting and investigation methodologies.
  • Strong technical writing, verbal communication and presentation skills.


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and broad work environment.

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.

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.