Senior Director, Analytical Development CMC
Centessa Pharmaceuticals
August 18, 2026
Remote friendly (Boston, MA)
United States
Operations
Key Responsibilities
- Lead analytical strategy for phase-appropriate method development, validation, and product characterization for multiple programs.
- Lead drug substance and drug product analytical development at third-party vendors, including method implementation, qualification/validation, and transfer (pre-IND through registrational programs).
- Review method validation protocols/reports and test data for release, stability, and characterization.
- Save/store documentation; generate stability result tables; file stability data for expiry and shelf-life assignments.
- Lead specification settings based on batch history and supporting analytical data.
- Serve as the CMC analytical representative in program development teams.
- Act as subject matter expert and role model for junior analytical scientists.
- Contribute to regulatory filing analytical CMC content (regulatory starting material justifications, specification justification, discriminatory/quality-control dissolution, structural elucidations).
- Draft/review internal technical reports and analytical sections for global submissions (IND, IMPD, NDA, MAA, etc.) and regulatory responses.
- Partner with Quality on analytical OOE/OOT/OOS investigations, deviations, and troubleshooting; participate in batch record review.
Qualifications
- PhD strongly preferred; advanced degree in chemistry, pharmaceutical sciences, or related field.
- 10+ years small molecule pharmaceutical industry experience.
- Extensive early-phase analytical development experience for small molecule oral solid dosage forms.
- Deep expertise in cGMP and ex-US regulatory requirements.
- Expertise in chemical/physical characterization (polymorphism, particle size, residual solvents, impurities incl. genotoxic/nitrosamines, forced degradation).
- Experience with analytical method development and GMP qualification/validation (assay, related substances, dissolution).
- Proven ability to manage outsourced analytical work (CDMOs) including assay development, stability, QC.
- Hands-on stability program design/management/interpretation (real-time, accelerated, forced degradation).
- Strong understanding of product quality attributes and control strategies; leadership and decision-making skills.
- Strong project management, organizational, prioritization, analytical planning, resource management, and budget oversight across global CDMO networks.
Compensation & Benefits
- Annual base salary range (Sr. Director): $165,000.00–$250,000.00; discretionary annual bonus; comprehensive benefits including 401(k), medical/dental/vision/life insurance, paid time off, and health/wellness program.
Work Location
- US-based with occasional travel.
Position
- Full-Time, Exempt.
- Lead analytical strategy for phase-appropriate method development, validation, and product characterization for multiple programs.
- Lead drug substance and drug product analytical development at third-party vendors, including method implementation, qualification/validation, and transfer (pre-IND through registrational programs).
- Review method validation protocols/reports and test data for release, stability, and characterization.
- Save/store documentation; generate stability result tables; file stability data for expiry and shelf-life assignments.
- Lead specification settings based on batch history and supporting analytical data.
- Serve as the CMC analytical representative in program development teams.
- Act as subject matter expert and role model for junior analytical scientists.
- Contribute to regulatory filing analytical CMC content (regulatory starting material justifications, specification justification, discriminatory/quality-control dissolution, structural elucidations).
- Draft/review internal technical reports and analytical sections for global submissions (IND, IMPD, NDA, MAA, etc.) and regulatory responses.
- Partner with Quality on analytical OOE/OOT/OOS investigations, deviations, and troubleshooting; participate in batch record review.
Qualifications
- PhD strongly preferred; advanced degree in chemistry, pharmaceutical sciences, or related field.
- 10+ years small molecule pharmaceutical industry experience.
- Extensive early-phase analytical development experience for small molecule oral solid dosage forms.
- Deep expertise in cGMP and ex-US regulatory requirements.
- Expertise in chemical/physical characterization (polymorphism, particle size, residual solvents, impurities incl. genotoxic/nitrosamines, forced degradation).
- Experience with analytical method development and GMP qualification/validation (assay, related substances, dissolution).
- Proven ability to manage outsourced analytical work (CDMOs) including assay development, stability, QC.
- Hands-on stability program design/management/interpretation (real-time, accelerated, forced degradation).
- Strong understanding of product quality attributes and control strategies; leadership and decision-making skills.
- Strong project management, organizational, prioritization, analytical planning, resource management, and budget oversight across global CDMO networks.
Compensation & Benefits
- Annual base salary range (Sr. Director): $165,000.00–$250,000.00; discretionary annual bonus; comprehensive benefits including 401(k), medical/dental/vision/life insurance, paid time off, and health/wellness program.
Work Location
- US-based with occasional travel.
Position
- Full-Time, Exempt.