Analytical Sr Scientist
Amgen
June 30, 2026
Remote friendly (Cambridge, MA)
United States
Other
Analytical Sr Scientist
Responsibilities:
- Integrate and apply platform and prior product knowledge to advance Amgen practices and ensure success from FIH study through to marketing application.
- Define analytical control strategies and implement methodologies for development of pivotal 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.
Basic Qualifications:
- 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
Preferred Qualifications:
- PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
- Pharmaceutical/biotech experience in process and product development and drug substance/drug product analytical method development
- Experience with small molecule analysis, structure elucidation, and solid-state characterization
- Experience with HPLC/UPLC, mass spectrometry, UV, NMR, FTIR, and solid-state characterization
- Experience developing methods for in-process testing, release, and stability testing for oral solid dosage (immediate and controlled release)
- Familiarity with USP monographs/chapters and ICH/FDA guidance (method transfer/validation, impurities, mutagenic impurities)
- Solid GLP/GMP understanding; technical transfer for non-GMP/GMP production and testing to external contract organizations
- Strong communication, cross-functional leadership, and technical writing skills
Application Instructions:
- Apply now; there is no application deadline—applications are accepted until a sufficient number are received or a candidate is selected.
Responsibilities:
- Integrate and apply platform and prior product knowledge to advance Amgen practices and ensure success from FIH study through to marketing application.
- Define analytical control strategies and implement methodologies for development of pivotal 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.
Basic Qualifications:
- 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
Preferred Qualifications:
- PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
- Pharmaceutical/biotech experience in process and product development and drug substance/drug product analytical method development
- Experience with small molecule analysis, structure elucidation, and solid-state characterization
- Experience with HPLC/UPLC, mass spectrometry, UV, NMR, FTIR, and solid-state characterization
- Experience developing methods for in-process testing, release, and stability testing for oral solid dosage (immediate and controlled release)
- Familiarity with USP monographs/chapters and ICH/FDA guidance (method transfer/validation, impurities, mutagenic impurities)
- Solid GLP/GMP understanding; technical transfer for non-GMP/GMP production and testing to external contract organizations
- Strong communication, cross-functional leadership, and technical writing skills
Application Instructions:
- Apply now; there is no application deadline—applications are accepted until a sufficient number are received or a candidate is selected.