Process Development Scientist - Potency and Characterization

Thousand Oaks, CA, US
Oct 23, 2020
Required Education
Bachelors Degree
Position Type
Full time

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.


What you will do

Let's do this. Let's change the world. In this vital role you will have responsibility for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays for our protein and cell therapy modalities.
  • Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations
  • May manage a team of lab associates to accomplish project results
  • Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions
  • Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions
  • 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
  • Plans and manages the generation of detailed analytical procedures used for product lot release, stability testing, and/or characterization including timelines, landmarks, methodological approaches, encouraged results, and vital resources
  • Keeps current in analytical development field including literature and technology development for groundbreaking and regulatory driven activities
  • Crafting and implementing analytical projects involving method development, qualification, and transfer
  • Provides critical evaluation of analytical data and results to support product development (for Process Development, Quality, etc.), investigations and regulatory submissions


What we expect of you

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

Basic Qualifications:

Doctorate degree


Master's degree & 4 years of cell biology, molecular biology, immunology or biochemistry experience


Bachelor's degree & 6 years of cell biology, molecular biology, immunology or biochemistry experience

Preferred Qualifications:
  • Expertise in cell culture and bioassay development for the quantitative determination of the biological activity of protein and cell therapy modalities
  • Expertise in cell-based bioassay development (method optimization, qualification, validation, technical transfer)
  • Expertise in flow cytometry preferable
  • Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies
  • Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines
  • Excellent documentation skills, is detail oriented
  • Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines preferred
  • Ability to expand analytical development expertise to a broader level of understanding in pharmaceutical R&D and commercialization
  • Experience with automation is desirable
  • Innovation - positive approach to challenges; champions new ideas and initiatives; brings out and utilizes others' creativity to improve unit performance
  • Client orientation- establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered; works well in teams
  • Leadership - supports teamwork and collaboration

Apply now

for a career that defies imagination

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

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.