Analytical Sr Scientist (Biotech)

Location: Corporate Headquarters, Thousand Oaks, California, United States; Conditions: Cambridge, Massachusetts

Salary: Expected annual salary range for this role in the U.S. excluding Puerto Rico; exact range not provided

Company

Amgen is a biotechnology company developing medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Develop analytical tools to understand key attributes of synthetic manufacturing processes and products.
• Apply platform and prior product knowledge from first-in-human studies through marketing applications.
• Define analytical control strategies and implement methods for pivotal clinical programs.
• Collaborate with drug substance, drug product, process development, analytical chemistry, organic chemistry, and formulation teams.
• Manage activities, deliverables, and timelines at contract manufacturing and testing sites.
• May lead and develop a small group of scientists.

Requirements

• PhD, PharmD, or MD with relevant postdoctoral experience; or a master’s degree with 3 years of scientific experience; or a bachelor’s degree with 5 years of scientific experience.
• Strong understanding of small-molecule analysis, structure elucidation, and solid-state characterization based on organic chemistry.
• Experience with analytical techniques including HPLC, UPLC, mass spectrometry, UV, NMR, FTIR, and solid-state characterization.
• Experience developing methods for in-process, release, and stability testing of immediate-release and controlled-release oral solid dosage products.
• Knowledge of USP monographs, ICH and FDA guidance, analytical method transfer and validation, impurities, GLP, and GMP requirements.
• Strong communication, technical writing, cross-functional leadership, and attention to detail.

Nice to have

• PhD in analytical chemistry, organic chemistry, materials science, biochemistry, biochemical engineering, or chemical engineering.
• Pharmaceutical or biotechnology industry experience in process and product development.
• Experience transferring non-GMP and GMP production and testing to external contract organizations.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off and career development opportunities.
• Flexible work models where applicable to the role.