Senior Manager of Analytical Chemistry

Job Summary

To support a growing CMC organization, the full-time Senior Manager of Analytical Chemistry will independently drive analytical CMC workstreams for small-molecule drug substances and products, managing external partners and overseeing technical deliverables in a fully remote environment.

Key responsibilities:

• Develop and execute phase-appropriate analytical strategies for assigned drug programs
• Independently manage analytical programs and vendor relationships, escalating key risks to CMC leadership
• Oversee development and validation of analytical methods and ensure regulatory compliance of technical documentation

Required qualifications:

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline with 6+ years of relevant experience; M.S. with 9+ years; or B.S. with 12+ years
• Substantial experience in analytical development and quality control of small-molecule drug products
• Demonstrated ability to manage outsourced analytical activities with CROs and CDMOs
• Strong knowledge of chromatographic and compendial techniques, including HPLC and mass spectrometry
• Experience authoring analytical CMC sections for regulatory submissions and technical reports