Sr. Scientist – Analytical Chemist
Amgen
- Cambridge, MA
- $125,274-143,832 per year
- Permanent
- Full-time
- Define analytical control strategies and implement methodologies for development of late phase clinical programs.
- Develop, optimize, and authorize analytical methods for synthetic small molecules, and/or synthetic peptide testing and characterization.
- Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
- Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry.
- Lead activities at contract manufacturing and testing sites.
- May lead method transfer to CMO or contract testing labs.
- Review and approve protocols, reports from CMO and contract testing labs.
- Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
- May lead and mentor a small group of scientists.
- Bachelor’s degree and 5 years of scientific experience OR
- Master’s degree and 3 years of scientific experience OR
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable (Doctorate degree or Doctorate degree completed by May 2024)
- PhD in Analytical Chemistry, Biochemistry with emphasis in mass spectrometry
- 2+ year’s post-PhD experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products.
- Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry.
- Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
- Experience in peptide method development, characterization, and analytical control strategy, especially having mass spectroscopy (MS) experience.
- Proficiency in a broad spectrum of structure elucidation and physicochemical techniques including MS, UV, NMR, FTIR, etc.
- Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
- Excellent 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
- Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.
- Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible