Amgen Process Development Sr. Associate 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 Senior Associate
What you will do
Let’s do this. Let’s change the world. In this dynamic role you will provide support for Amgen’s biologics drug product and process design. The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s drug product commercialization and lifecycle management. The Sr. Associate will integrate and utilize platform capabilities and data analytics/visualization to advance Amgen’s pipeline and ensure success of the commercialization process. Responsibilities include:
Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development in support of commercialization and life cycle management of biologics.
Support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).
Evaluate process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization (cake appearance, moisture, reconstitution time), and particle quantitation/characterization.
Provide support for clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
Conduct analysis of data generated from the above listed activities, including statistical analysis using JMP, SAS, etc.
Apply digital tools and techniques to automate data structuring, integration with electronic notebooks and analysis of large and diverse datasets.
Author/review technical documents: technical protocols, technical reports, regulatory documents, etc.
Clearly and consistently communicate progress reports and presentations to ensure management and functional awareness of and engagement in current status, plan forward, and forthcoming program needs.
Participate in cross-functional teams in a fast-paced environment to progress product development.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a collaborative partner with these qualifications.
- Master's Degree OR Bachelor's Degree and 2 years of Scientific, Engineering or Operations experience
Degree in Engineering, Chemistry, Pharmaceutics, Materials Science, or related subject area.
Aseptic processing experience and familiarity with cGMPs.
2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development.
Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, CE, HIAC, MFI).
Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality.
Experience with regulatory filings and compliance issues
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and stay in sync with company policies.
Self-motivation, resourcefulness and a positive demeanor.
Critical thinking, problem solving and independent research skills.
Good organizational skills with strong attention to detail.
Excellent communication (oral and written).
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.