Process Development Associate Scientist

Job Summary

Based in Thousand Oaks, CA, the Process Development Associate Scientist will provide technical input and support to Amgen's biologics parenteral drug product commercialization and advancement of aseptic manufacturing process development. This role is important for Amgen's success and will be a key contributor to drug product and process development, commercialization and life cycle management of Amgen's parenteral product portfolio.

As such the Process Development Associate Scientist will operate in product and process development and/or manufacturing environments and will be responsible for the design and execution of characterization studies, evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes, authoring high-quality process transfer and other technical documents, and participating in authoring relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities.

The Process Development Associate Scientist will apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to support nonconformance investigations and development of corrective/preventive actions. As a key contributor to Amgen's commercialization development and aseptic process introduction into clinical and commercial facilities, the Process Development Associate Scientist will integrate and utilize knowledge and information generated by cross functional (engineering, analytical, quality, regulatory, clinical and commercial manufacturing) teams to utilize Amgen platforms and capabilities to ensure success through the commercialization lifecycle.

Responsibilities include:

• Work within a team of process scientists and/or engineers to design, execute, document, and generate

primary data packages related to process development and technology transfer, while applying their experience in aseptic processing and unit operation characterization

• Support technology transfers of pipeline and commercial products as well as lifecycle management of

commercial products

• Participate in global cross-functional teams, working effectively in a highly matrixed team environment

to advance programs

Basic Qualifications

Master's degree and 2 years of scientific experience

OR

Bachelor's degree and 4 years of scientific experience

Preferred Qualifications

• 6+ years of drug product process development experience in the pharmaceuticals/biotechnology

industry

• Familiarity with aseptic processing, manufacturing, cGMPs, statistical design, analysis of experiments,

and process characterization

• Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root

cause analysis, and risk assessment tools

• The ability to use engineering principles to leverage bench and pilot scale models for process

performance characterization

• Problem solving and communication skills

• Knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials,

syringes, cartridges, devices, disposables, modeling and the associated GMP/Device documentation and

regulatory filings

• Experience with conducting statistical evaluations of data to evaluate statistical significance, assess

potential correlations and evaluate process capability and/or perform Monte Carlo simulations.

• Ability to learn and act on dynamic information at a rapid pace

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.

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.