29 days old

Process Development Scientist

Amgen
West Greenwich, RI 02817
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  • Job Code
    122852806
Amgen

Job ID: R-103096
Location: West Greenwich, RI, US 02817
Additional Location: US - Massachusetts - Cambridge

We are seeking: Scientist - Commercial Attribute Sciences

Amgen discovers, develops and delivers innovative human therapeutics. 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 a Process Development Scientist, ASTL (Attribute Sciences Team Lead), you will be a member of the Commercial Attribute Science.

Responsibilities:

  • Analytical leadership of a commercial program(s) including method lifecycle management, method transfer, validation and remediation.
  • Represent Attribute Sciences as a core member of Product Delivery Team(s)
  • Provide analytical subject matter expert 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 and Supply Chain.
  • As ASTL, will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success of the commercial portfolio.


Basic Qualifications:

  • Doctorate degree
  • OR
  • Master's degree and 4 years of Scientific experience
  • OR
  • Bachelor's degree and 6 years of Scientific experience


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.
  • Expert 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.
  • Demonstrated experience working in matrix environment.
  • Experience in technical transfer for GMP production and testing to external contract organizations, able to manage deliverables 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.


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages 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.

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.



PI122852806
Posted: 2020-08-22 Expires: 2020-09-23

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Process Development Scientist

Amgen
West Greenwich, RI 02817

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