Associate Director/Director, Drug Product - CMC

About the Role

Centessa’s CMC group is seeking an (Associate) Director of Drug Product to support early stage programs. The successful candidate will lead nonclinical and clinical formulation development, manage CROs and CDMOs, and oversee the design and manufacturing of small molecule drug products from Phase I to Phase III. This role involves coordinating with vendors domestically and internationally, with occasional travel required.

Responsibilities

• Manage and guide external vendors (CROs, CDMOs) to execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs).
• Design and develop nonclinical formulations (oral, subcutaneous, intravenous) to ensure stability, bioavailability, and effective drug delivery in animal models.
• Oversee execution of nonclinical formulation stability and compatibility studies.
• Support clinical formulation development of oral solid dosage forms as needed.
• Author, review, and approve development and dose preparation protocols and reports.
• Review formulation-related sections of protocols and reports for Pharmacokinetic (PK), Pharmacodynamic (PD), and safety studies.
• Represent CMC in cross-functional team meetings, providing guidance on nonclinical formulation, drug substance (DS) and drug product (DP) stability, and supply.
• Coordinate shipments to support nonclinical and clinical development supply requirements.
• Assist in compiling formulation-related documentation for regulatory submissions (e.g., IND, CTA).
• Collaborate with cross-functional CMC groups, including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality, and regulatory teams.

Qualifications

• BS or MS in Pharmaceutical Sciences or a related discipline; PhD strongly preferred.
• 10+ years of experience in small molecule formulation development, supporting nonclinical and clinical programs across oral, subcutaneous, and intravenous dosage forms.
• Deep understanding of formulation development and manufacturing of poorly soluble (BCS Class II/IV) small molecule compounds.
• Strong knowledge of pharmaceutical and engineering principles for liquid and solid dosage form development at clinical and commercial scale.
• Proficiency with analytical and solid-state characterization techniques (HPLC/UPLC, XRPD, DSC, TGA, DVS, and related methodologies).
• Experience managing external development partners (CROs, CDMOs, CMOs) and coordinating pharmaceutical product development activities.
• Working knowledge of cGMP requirements and pharmaceutical development standards.
• Strong strategic, analytical, and problem-solving skills with the ability to anticipate risks and drive high-quality results.
• Excellent communication, interpersonal, and project leadership skills to influence stakeholders and manage cross-functional relationships.
• Highly organized, detail-oriented, and self-directed, with the ability to manage multiple priorities in a fast-paced environment.
• Willingness to travel domestically and internationally (5-10%).

Pay

The annual base salary range for this position is $170,000 to $195,000. Individual compensation within this range will be determined based on qualifications, skills, experience, job knowledge, and location. This role is also eligible for a discretionary annual bonus.

Benefits

• Comprehensive benefits package, including a 401(k) plan.
• Company-sponsored medical, dental, vision, and life insurance.
• Generous paid time off.
• Health and wellness program.

Schedule

This is a full-time, exempt position based in the US, with occasional travel required.