Amgen Process Development Scientist in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
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.
Process Development Scientist
What you will do
Let’s do this. Let’s change the world. In this dynamic role you will work on developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and biological characterization assays. Responsibilities include:
Developing and implementing state-of-the-art and fit-for-purpose potency and biological characterization methods for product release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations
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, achievements, methodological approaches, expected results, and vital resources
Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities
Designing 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 partner with these qualifications.
- Doctorate degree in Cell Biology, Molecular Biology, Immunology or Biochemistry subject area OR Master’s degree & 2 years of Scientific experience OR Bachelor’s degree & 6 years of Scientific experience
Expertise in cell culture and bioassay development for the quantitative determination of the biological activity of large molecule therapeutics
Expertise in cell-based bioassay development (method optimization, qualification, validation, technical transfer)
Expertise in immunology preferred
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.
Some of the vast rewards of working here
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.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.
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.