Amgen

Process Development Senior Scientist - Commercial Attribute Science

Employer
Amgen
Location
Thousand Oaks, CA
Posted
May 28, 2021
Ref
R-118154
Required Education
Bachelors Degree
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Process Development Senior Scientist

Live

What you will do

Lets do this. Lets change the world.

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences 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 peoples lives.

Job summary

Amgen's Commercial Attribute Sciences group in Thousand Oaks, CA is seeking a leader. The successful candidate will be responsible for leading a team of scientists to provide technical oversight in support of method related testing challenges, incoming method transfer and commercial investigations spanning various analytical platforms which may include Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), synthetic peptides and live oncolytic viruses. Responsibilities also include supporting implementation of new analytical technology, incoming tech transfer, and management of Commercial ASTLs (Attribute Sciences Team Leads). The successful candidate will be a part of a team at the interface with Commercial Quality, Manufacturing, Drug Product Process Development, and Contract Manufacturing, liaising with the global Attribute Sciences network to ensure that site needs are addressed. This leadership role of the Commercial Attribute Sciences team at Thousand Oaks will laisse with site leadership as well as Attribute Sciences functional leadership across Amgen.

Role Responsibilities:
  • Technical leadership in support of troubleshooting method related testing challenges, incoming method transfer and commercial investigations

  • Independent authorship and management review of technical reports, variations and responses to analytical questions from health authorities

  • Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions

  • Generating, analyzing, and critical evaluation of analytical data to support product development investigations, method remediation and regulatory submissions

  • Supporting ASTLs (May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation

  • Supporting career development and mentoring staff

  • Duties may include establishing timelines, milestones, methodological approaches, expected results, necessary resources and communication to global cross-functional stakeholders

  • Keeping current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientific leader we seek is a collaborative team-player with these qualifications.

Basic Qualifications

Doctorate degree and 2 years of scientific experience

OR

Masters degree and 5 years of scientific experience

OR

Bachelors degree and 8 years of scientific experience

Preferred Qualifications
  • PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering

  • 5+ years pharmaceutical/biotech experience in process and product development and analytical method development

  • Deep understanding of product quality attributes and control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product.

  • Commanding knowledge of analytical methods/technologies such as Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), synthetic peptides and live oncolytic viruses

  • Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing.

  • Strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.

  • Strong understanding of drug substance and drug product manufacturing processes

  • Experience with regulatory filings and commercial quality systems

  • Experience working closely with process engineers and quality control laboratories to generate and interpret analytical data to provide enhanced understanding and guidance around process understanding and control

  • Experience with QbD and PAT, as applied to pharmaceutical development

  • Experience managing and transferring commercial production and test methods

  • Experience managing a team

  • Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. advising and defending the Quality Target Product Profile

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization

  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Equal Opportunity Statement

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 a 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 an 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.