Process Development Associate
The Pivotal Drug Substance Technologies organization develops drug substance and API manufacturing processes for all late-stage programs across the Amgen portfolio. Located at our Thousand Oaks, CA campus, responsibilities of this lab-based position will include:
Support of Drug Substance Process Development for large molecule programs in late stage clinical and commercial development, including commercial process development and process characterization. Typical project goals include improvements in yield, efficiency and reliability and/or changes in equipment, scale, and raw materials.
Performing small-scale bioprocessing experiments encompassing both upstream (cell culture) and downstream (purification) operations. Cell culture responsibilities may include maintaining cultures in shake flasks, culture bags, and benchtop bioreactors. Purification experiments include, but are not limited to, protein chromatography, filtrations, and UF/DF operations.
Designing suitable experiments and analyzing results to draw meaningful conclusions. Communication of work through oral presentations and written documentation including technical reports and GMP documents to support regulatory filings.
Providing scientific technical support for technology transfer of processes to manufacturing sites.
Bachelor's degree or Bachelor's Degree completed by June 2018
Associate's degree & 4 years of Process Development or Operations experience
High school diploma / GED and 6 years of Process Development or Operations experience
BS. in Chemical Engineering, Biochemical Engineering, Life Sciences with 1 years experience in biotech/pharmaceutical industry.
Ability to apply fundamental scientific and engineering principles to resolve processing issues and evaluate opportunities for process improvements
Demonstrated success working with diverse team members in a dynamic, cross-functional environment
Experience working with mammalian cell cultures, particularly in bioreactors, or experience performing protein purification operations including using Akta chromatographic systems
Familiarity with design of experiments (DOE) and/or qualification of scale-down models
Excellent written and verbal communication skills
Ability to work occasional evenings and weekends
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.
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.