Senior Director, Analytical Development CMC — Analytics

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company; Boston (MA); On-site; USD 165,000 - 250,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision insurance

Life insurance

Generous paid time off

Wellness program

Job summary

Centessa Pharmaceuticals is seeking a Senior Director of Analytical Development in the CMC group to lead method development, validation, and strategy for small molecule API and drug products. You will oversee outsourced analytical activities at CDMOs, ensure compliance with cGMP and regulatory guidance, and partner with drug substance and product teams across programs.

Travel to vendors domestically and internationally, mentor senior scientists, and contribute to regulatory filings including

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, 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.
• 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 starting material justifications, specifications, and dissolution development.
• Review and drafting of internal technical reports and information for analytical sections in global submission documents (IND, IMPD, NDA, MAA, etc).
• Work cross-functionally with Quality as a technical expert to aid in analytical investigations and deviations.
• Active participation in batch record review.

Skills

Analytical development

CDMO management

Regulatory guidance

Small molecules

GMP/QA

Stability programs

Leadership

Project management

Education

PhD in Chemistry/Pharmaceutical Sciences

Job description

Centessa Pharmaceuticals is seeking a Senior Director of Analytical Development in the CMC group to lead method development, validation, and strategy for small molecule API and drug products. You will oversee outsourced analytical activities at CDMOs, ensure compliance with cGMP and regulatory guidance, and partner with drug substance and product teams across programs.

Travel to vendors domestically and internationally, mentor senior scientists, and contribute to regulatory filings including