Senior Director, Analytical Development, CMC Small Molecule

Centessa Pharmaceuticals plc is seeking a Senior Director of Analytical Development for its CMC group. The successful candidate will have hands-on experience in the development and validation of raw material, in-process, small molecule drug substance, and solid oral dose drug product methods at all stages of development.

Requirements

• Hands-on experience in the development and validation of raw material, in-process, small molecule drug substance, and solid oral dose drug product methods at all stages of development
• Comprehensive working knowledge of cGMP and Regulatory guidance as they relate to regulatory starting material, drug substance and drug product development, characterization, release, and stability testing of small molecules is paramount
• Collaborative work in a team environment to lead drug substance and drug product analytical development activities primarily at third-party vendors
• Act as the CMC team analytical representative member in program development teams
• Lead specification settings based upon batch history and supporting analytical data
• Act as role model and subject matter expert for junior analytical scientists
• Significantly contribute to CMC analytical aspects of regulatory filings including regulatory starting material justifications, justification of specifications, discriminatory and quality control dissolution method development, and structural elucidations
• Active participation in batch record review
• Strong analytical planning, resource management, and budget oversight skills across global CDMO networks
• Effective decision-maker and communicator, able to work independently while collaborating across functions and organizational levels

Benefits

• 401(k) plan
• Company-sponsored medical, dental, vision, and life insurance
• Generous paid time off
• Health and wellness program