Amgen Process Development Scientist, Pivotal Attribute Science in Cambridge, Massachusetts
Define analytical strategies for development of pivotal phase clinical programs
Collaborate closely with drug substance and drug product process development colleagues
Manage activities at contract manufacturing and testing sites
Leverage analytical science to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline
May lead and develop a small group of scientists
Master's degree and 4 years of Scientific experience
Bachelor's degree and 6 years of Scientific experience
PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
2+ year's post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development
Strong understanding of small molecule analysis, spectroscopic techniques with an emphasis toward Process Analytical Technologies (PAT) for process understanding and process control, separation science, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry. Solid understanding of analytical method developments toward solid oral formulation support, including dissolution method development. Knowledge of large molecule analysis.
Experience in a wide variety of analytical and physicochemical techniques including chromatography (High- Performance Liquid Chromatography: HPLC, Gas Chromatography: GC, Capillary Electrophoresis: CE) mass spectrometry, Ultraviolet: UV, Nuclear Magnetic Resonance: NMR, Fourier Transform Infrared: FTIR, Raman, particle size determination, crystal characterization, dissolution, etc.
Developing and implementing methods for in-process testing, release and stability testing
Experience in analytical testing requirements for immediate release and controlled release solid dosage forms, liquid formulation or lyophilized formulation
Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development, etc.
Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner
Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, manage deliverables against timelines
Strong communication skills and ability to provide cross-functional leadership and guidance to Chemistry, Manufacturing, and Controls (CMC) and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
Works well in cross-functional teams, and across various geographic locations in different time zones
Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
Experience with hybrid modality and protein based drug development is beneficial (antibody drug conjugates, peptide, PEGylated drugs, monoclonal antibody, fusion protein, etc.)
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.
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.