Senior Director, Analytical Development CMC

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company•Boston, MA

22h•$165,000 - $250,000•Onsite

About The Position

Centessa Pharmaceuticals is seeking a Senior Director of Analytical Development within the CMC group. This role will focus on the development and validation of analytical methods for raw materials, in-process samples, small molecule drug substance, and solid oral drug product across all stages of development. The position involves driving analytical method gap assessments, method development, and strategy at Contract Development and Manufacturing Organizations (CDMOs), and collaborating with drug substance and drug product teams. A strong understanding of current Good Manufacturing Practices (cGMP) and regulatory guidance related to regulatory starting materials, drug substance, and drug product development, characterization, release, and stability testing of small molecules is essential. The Senior Director will be responsible for all analytical CMC data from external CDMOs to ensure company deliverables and timelines are met. Travel to domestic and international vendors is required.

Requirements

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 levels

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.