Analytical Sr Scientist

Responsibilities

• 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.

Qualifications

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Masters degree and 3 years of Scientific experience OR Bachelors 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
• 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
• 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
• Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• Works well in cross-functional teams, and across various geographic locations in different time zones
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents