Analytical Scientist

Analytical Scientist – Amgen

• Integrate and apply platform and prior product knowledge to advance Amgen practices and ensure success from first-in-human study through to marketing application.
• Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs.
• 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.

• Doctorate degree OR Master’s degree and 2 years of scientific experience OR Bachelor’s degree and 4 years of scientific experience.

• 4 years of industry experience plus Master’s in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, or Chemical Engineering.
• Experience in pharmaceutical or biotech industry on 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 informed by organic chemistry knowledge.
• Experience with chromatography (HPLC and UPLC), mass spectrometry, UV, NMR, FTIR, solid‑state characterization, and related techniques.
• Developing and implementing methods for in‑process testing, release, and stability testing.
• Experience with analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
• Familiarity with USP monographs and chapters, and ICH/FDA guidance on analytical method transfer, validation, impurities, and mutagenic impurities.
• Solid understanding of GLP and GMP requirements and application in a phase‑appropriate manner.
• Experience in technical transfer for non‑GMP and GMP production and testing to external contract organizations, managing deliverables against timelines.
• Strong communication skills and ability to provide cross‑functional leadership and guidance to CMC and non‑clinical teams, including defending the Quality Target Product Profile.
• Works well in cross‑functional teams and across various geographic locations and time zones.
• Excellent technical writing skills and attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents.

Expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $ – $ USD.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. Amgen will provide reasonable accommodation for individuals with disabilities.