Senior Analytical Scientist

Responsibilities

• Work closely with a team of analytical chemists, organic chemists and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for synthetic manufacturing processes and synthetic products.
• Integrate and successfully 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 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 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
• PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
• Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development is a plus.
• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry.
• Experience in a wide variety of analytical techniques including chromatography (HPLC and UPLC) mass spectrometry, UV, NMR, FTIR, solid state characterization, etc.
• Developing and implementing methods for in-process testing, release and stability testing.
• Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
• Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner.
• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents.