Note: The job is a remote job and is open to candidates in USA. Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is seeking a Senior Director of Analytical Development for its CMC group. The role leads analytical strategy, method development and validation, and analytical support for small-molecule drug substance and drug product programs, including work with external CDMOs and regulatory filings.
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
Skills
- 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
- 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
- Advanced degree in chemistry, pharmaceutical sciences, or related field
- 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
- PhD strongly preferred
Benefits
- Full-time equivalent employees are eligible for a company bonus, depending in part on company and individual performance.
- Eligible employees may participate in a company-sponsored 401(k).
- Pension.
- Vacation benefits.
- Eligible employees may participate in medical, dental, vision, and prescription drug benefits.
- Flexible benefits, e.g., healthcare and/or dependent day care flexible spending accounts.
- Life insurance and death benefits.
- Certain time off and leave of absence benefits.
- Well-being benefits, e.g., employee assistance program, fitness benefits, and employee clubs and activities.
- Remote work.
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