Analytical Chemist - Process Development Senior Scientist
Amgen - Thousand Oaks, CA
posted 16 days ago
About the position
Amgen is currently seeking a Sr. Scientist - Analytical Chemist in our Pre-Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for early phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of early phase drug substances and drug products. The individual 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 Sr. Scientist will integrate and successfully use platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND filings. The Sr. Scientist should have strong analytical chemistry and communication skills.
Responsibilities
- Analytical method development, validation and troubleshooting for small molecule drug substances and drug products and in-process testing.
- Define analytical control strategies and implement methodologies for development of early phase clinical programs.
- Collaborate 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.
Requirements
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR
- Master's degree and 3 years of scientific experience OR
- Bachelor's degree and 5 years of scientific experience
Nice-to-haves
- PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
- 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 physiochemical techniques including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.
- Ability to develop and implement methods for in-process, 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, mutagenic 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, handle deliverables against timelines.
- Strong communication skills and ability to provide cross-functional leadership and guidance to 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 synthesis, method development and attribute characterization for small molecules, peptides or oligonucleotides
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
