Senior Director, Drug Product CMC
Centessa Pharmaceuticals
August 18, 2026
On-site
Boston, MA
Operations
Key Responsibilities
- Directly manage 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 animal-model drug delivery.
- Design and oversee nonclinical formulation stability and compatibility studies.
- Support clinical formulation development of oral solid dosage forms, as needed.
- Author and/or review/approve development and dose preparation protocols and reports.
- Review formulation-related sections for PK, PD, and safety study protocols/reports.
- Represent CMC with nonclinical formulation, DS/DP stability, and supply guidance in cross-functional meetings.
- Coordinate shipments for nonclinical and clinical development supply to CDMO/CRO sites.
- Compile formulation-related documentation for regulatory submissions (e.g., IND, CTA).
- Collaborate with cross-functional CMC groups (discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality, regulatory).
Qualifications
- Advanced degree in Chemistry/Pharmaceutical Sciences (Ph.D. strongly preferred).
- 10+ years drug product/formulation development for nonclinical and clinical small molecules (oral, subcutaneous, IV).
- Deep expertise developing/manufacturing poorly soluble (BCS II/IV) compounds.
- Strong understanding of liquid/solid dosage form development principles through clinical and commercial manufacturing.
- Analytical/solid-state characterization knowledge (HPLC/UPLC, XRPD, DSC, TGA, DVS).
- Experience managing external partners (CRO/CDMO/CMO) and understanding of cGMP.
- Ability to lead multiple complex programs in a fast-paced environment.
- Excellent communication and stakeholder management; hands-on strategic decision-making.
- Willing/able to travel domestically and internationally as needed.
Position: Full-Time, Exempt
- Directly manage 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 animal-model drug delivery.
- Design and oversee nonclinical formulation stability and compatibility studies.
- Support clinical formulation development of oral solid dosage forms, as needed.
- Author and/or review/approve development and dose preparation protocols and reports.
- Review formulation-related sections for PK, PD, and safety study protocols/reports.
- Represent CMC with nonclinical formulation, DS/DP stability, and supply guidance in cross-functional meetings.
- Coordinate shipments for nonclinical and clinical development supply to CDMO/CRO sites.
- Compile formulation-related documentation for regulatory submissions (e.g., IND, CTA).
- Collaborate with cross-functional CMC groups (discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality, regulatory).
Qualifications
- Advanced degree in Chemistry/Pharmaceutical Sciences (Ph.D. strongly preferred).
- 10+ years drug product/formulation development for nonclinical and clinical small molecules (oral, subcutaneous, IV).
- Deep expertise developing/manufacturing poorly soluble (BCS II/IV) compounds.
- Strong understanding of liquid/solid dosage form development principles through clinical and commercial manufacturing.
- Analytical/solid-state characterization knowledge (HPLC/UPLC, XRPD, DSC, TGA, DVS).
- Experience managing external partners (CRO/CDMO/CMO) and understanding of cGMP.
- Ability to lead multiple complex programs in a fast-paced environment.
- Excellent communication and stakeholder management; hands-on strategic decision-making.
- Willing/able to travel domestically and internationally as needed.
Position: Full-Time, Exempt