Associate Director/Director, Drug Product - CMC
Centessa Pharmaceuticals
August 20, 2026
Remote friendly (Boston, MA)
United States
Operations
(Associate) Director, Drug Product (CMC)
Key Responsibilities
- Manage and guide external vendors (CROs, CDMOs) to execute physiochemical characterization and pre-formulation studies for NCEs.
- Design and develop nonclinical formulations (oral, subcutaneous, IV) to ensure stability, bioavailability, and effective delivery in animal models.
- Design and oversee nonclinical formulation stability and compatibility studies.
- Support clinical formulation development of oral solid dosage forms, as needed.
- Author and/or review and approve development and dose preparation protocols and reports.
- Review formulation sections of protocols/reports for PK, PD, and safety studies.
- Provide nonclinical formulation, DS and DP stability, and supply guidance at internal/external cross-functional meetings.
- Coordinate shipments for nonclinical and clinical development supply needs across CDMO/CRO sites.
- Compile formulation-related documentation for regulatory submissions (e.g., IND, CTA) for nonclinical requirements.
- Collaborate with cross-functional CMC teams (discovery, nonclinical, clinical, project management, sourcing, supply chain, quality, regulatory, etc.).
Qualifications
- BS or MS in Pharmaceutical Sciences (or related); PhD strongly preferred.
- 10+ years’ small molecule formulation development experience supporting nonclinical and clinical programs across oral, subcutaneous, and IV.
- Deep understanding of poorly soluble (BCS Class II/IV) small molecule formulation development and manufacturing.
- Knowledge of liquid/solid dosage form principles at clinical and commercial scale.
- Proficiency with analytical/solid-state characterization (HPLC/UPLC, XRPD, DSC, TGA, DVS, etc.).
- Experience managing external development partners (CROs/CDMOs/CMOs).
- Working knowledge of cGMP requirements and pharmaceutical development standards.
- Strong strategic/analytical problem-solving; anticipate risks and drive timely results.
- Excellent communication and project leadership; ability to influence stakeholders.
- Highly organized, detail-oriented; ability to manage multiple priorities; travel domestically/internationally (5–10%).
Compensation/Benefits
- Base salary range: $170,000–$195,000; discretionary annual bonus; 401(k), medical/dental/vision/life insurance, paid time off, health and wellness program.
Work Location
- US-based; occasional travel.
Position: Full-Time, Exempt
Key Responsibilities
- Manage and guide external vendors (CROs, CDMOs) to execute physiochemical characterization and pre-formulation studies for NCEs.
- Design and develop nonclinical formulations (oral, subcutaneous, IV) to ensure stability, bioavailability, and effective delivery in animal models.
- Design and oversee nonclinical formulation stability and compatibility studies.
- Support clinical formulation development of oral solid dosage forms, as needed.
- Author and/or review and approve development and dose preparation protocols and reports.
- Review formulation sections of protocols/reports for PK, PD, and safety studies.
- Provide nonclinical formulation, DS and DP stability, and supply guidance at internal/external cross-functional meetings.
- Coordinate shipments for nonclinical and clinical development supply needs across CDMO/CRO sites.
- Compile formulation-related documentation for regulatory submissions (e.g., IND, CTA) for nonclinical requirements.
- Collaborate with cross-functional CMC teams (discovery, nonclinical, clinical, project management, sourcing, supply chain, quality, regulatory, etc.).
Qualifications
- BS or MS in Pharmaceutical Sciences (or related); PhD strongly preferred.
- 10+ years’ small molecule formulation development experience supporting nonclinical and clinical programs across oral, subcutaneous, and IV.
- Deep understanding of poorly soluble (BCS Class II/IV) small molecule formulation development and manufacturing.
- Knowledge of liquid/solid dosage form principles at clinical and commercial scale.
- Proficiency with analytical/solid-state characterization (HPLC/UPLC, XRPD, DSC, TGA, DVS, etc.).
- Experience managing external development partners (CROs/CDMOs/CMOs).
- Working knowledge of cGMP requirements and pharmaceutical development standards.
- Strong strategic/analytical problem-solving; anticipate risks and drive timely results.
- Excellent communication and project leadership; ability to influence stakeholders.
- Highly organized, detail-oriented; ability to manage multiple priorities; travel domestically/internationally (5–10%).
Compensation/Benefits
- Base salary range: $170,000–$195,000; discretionary annual bonus; 401(k), medical/dental/vision/life insurance, paid time off, health and wellness program.
Work Location
- US-based; occasional travel.
Position: Full-Time, Exempt