Senior) Director, Analytical Development CMC

Senior Director, Analytical Development CMC

Description of Role

Centessa’s CMC group is seeking a Senior Director of Analytical Development within the 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.

Reporting to the Executive Director, this role will drive analytical method gap assessments, method development, and strategy at various CDMOs and liaise cross-functionally with drug substance and drug product teams across programs. 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.

This position will be accountable for all analytical CMC data from external CDMOs to meet company deliverables and timelines. Travel to vendors both domestically and internationally will be required.

Key Responsibilities

• Lead analytical strategy related to phase-appropriate method development, validation, and product characterization for multiple programs
• Collaboratively work in a team environment to lead drug substance and drug product analytical development activities primarily at third-party vendors including method implementation, qualification/validation, and transfer in support of pre-IND through Registrational programs
• Review method validation protocol and reports, and test data for release, stability, and characterization
• Save and store documentation, generate stability result tables, file stability data for expiry and shelf-life assignments
• Lead specification settings based upon batch history and supporting analytical data
• Act as the CMC team analytical representative member in program development teams
• 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
• Review and drafting of internal technical reports and information for analytical sections in global submission documents and modules (e.g. IND, IMPD, NDA, MAA, etc) as well as responses to Regulatory requests for information
• Work cross-functionally with Quality as a technical expert to aid in analytical OOE/OOT/OOS investigations, deviations, and other troubleshooting
• Active participation in batch record review

Qualifications

• Advanced degree in chemistry, pharmaceutical sciences, or related field (PhD strongly preferred)
• 10+ years of small molecule pharmaceutical industry experience
• Extensive experience in early phase analytical development of small molecule oral solid dosage forms
• Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
• Strong technical background in chemical and physical characterization, including polymorphism, particle size, residual solvents, process impurities (e.g., genotoxic, nitrosamines), and forced degradation mechanisms
• Significant experience in analytical method development and GMP qualification/validation, including assay, related substances, and dissolution
• Proven ability to manage and direct outsourced analytical activities, including assay development, stability, and quality control at CDMOs
• Hands-on experience designing, managing, and interpreting stability programs (real-time, accelerated, and forced degradation)
• Strong understanding of product quality attributes and control strategies for small molecule synthetic processes
• Demonstrated leadership in coordinating analytical and broader CMC activities supporting development and commercialization
• Excellent project management, organizational, and prioritization skills in fast-paced, multi-project environments
• 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…