Analytical Scientist
Amgen
8 hours ago
Remote friendly (Cambridge, MA)
United States
Operations
Analytical Scientist
Responsibilities:
- Integrate and apply platform and prior product knowledge to advance analytical practices; ensure success from First-in-Human (FIH) through to marketing application.
- Define analytical control strategies and implement methodologies for pivotal phase clinical program development.
- 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
- OR Master’s degree and 2 years of scientific experience
- OR Bachelor’s degree and 4 years of scientific experience
Preferred Qualifications / Skills:
- 4 years of industry experience plus a Master’s in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering.
- Experience in pharmaceutical/biotech process and product development and drug substance/drug product analytical method development.
- Strong understanding of small molecule analysis, structure elucidation, and solid-state characterization.
- Experience with analytical techniques including HPLC/UPLC, mass spectrometry, UV, NMR, FTIR, and solid-state characterization.
- Experience developing methods for in-process testing, release, and stability testing for immediate and controlled release oral solid dosage products.
- Familiarity with USP monographs/chapters and ICH/FDA guidance (method transfer/validation, impurities, mutagenic impurities).
- Solid understanding of GLP/GMP requirements.
- Experience with technical transfer to external (non-GMP and GMP) contract organizations and managing deliverables to timelines.
- Strong communication; cross-functional leadership for CMC and non-clinical teams.
- Works well in cross-functional teams and across time zones.
- Excellent technical writing skills and attention to detail.
Benefits:
- Retirement and Savings Plan, medical/dental/vision, life/disability insurance, flexible spending accounts; discretionary bonus/incentives; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions:
- Apply now; no application deadline—applications accepted until a sufficient number of candidates are received or a selection is made.
Responsibilities:
- Integrate and apply platform and prior product knowledge to advance analytical practices; ensure success from First-in-Human (FIH) through to marketing application.
- Define analytical control strategies and implement methodologies for pivotal phase clinical program development.
- 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
- OR Master’s degree and 2 years of scientific experience
- OR Bachelor’s degree and 4 years of scientific experience
Preferred Qualifications / Skills:
- 4 years of industry experience plus a Master’s in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering.
- Experience in pharmaceutical/biotech process and product development and drug substance/drug product analytical method development.
- Strong understanding of small molecule analysis, structure elucidation, and solid-state characterization.
- Experience with analytical techniques including HPLC/UPLC, mass spectrometry, UV, NMR, FTIR, and solid-state characterization.
- Experience developing methods for in-process testing, release, and stability testing for immediate and controlled release oral solid dosage products.
- Familiarity with USP monographs/chapters and ICH/FDA guidance (method transfer/validation, impurities, mutagenic impurities).
- Solid understanding of GLP/GMP requirements.
- Experience with technical transfer to external (non-GMP and GMP) contract organizations and managing deliverables to timelines.
- Strong communication; cross-functional leadership for CMC and non-clinical teams.
- Works well in cross-functional teams and across time zones.
- Excellent technical writing skills and attention to detail.
Benefits:
- Retirement and Savings Plan, medical/dental/vision, life/disability insurance, flexible spending accounts; discretionary bonus/incentives; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions:
- Apply now; no application deadline—applications accepted until a sufficient number of candidates are received or a selection is made.