Process Development Scientist - Analytical Chemist
Amgen is currently seeking a Scientist - Analytical Chemist in our Pre-Pivotal Attribute Sciences Department in Cambridge, MA. This group is responsible for early phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of early phase drug substances and drug products. The Scientist will work closely with a team of analysts and scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes in product and process for early phase synthetic programs. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND filings.
- Define analytical strategies for development of early phase clinical programs
- Leverage analytical science to help drive efficient development and scalable understanding of processes and products in Amgen's pipeline.
- Collaborate closely with drug substance and drug product process development colleagues
- Manage activities at contract manufacturing and testing sites
- 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, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry
- Experience in a wide variety of structure elucidation and physicochemical techniques including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.
- Developing and implementing methods for in-process testing, release and stability testing
- Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products
- Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutigenic impurities, early phase development, etc.
- Solid understanding of GLP and 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