Senior Director, Drug Product CMC

About the role

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company, is seeking a Senior Director of Drug Product within the CMC group. Reporting to the Executive Director, CMC, this position will primarily lead work with external vendors and oversee non-clinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines. Travel to domestic and international vendors required.

Responsibilities

• Directly manage external vendors, such as Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs).
• Design and develop nonclinical formulations of drug candidates (oral, subcutaneous, and intravenous) to ensure stability, bioavailability and effective drug delivery in animal models.
• Design and oversee execution of 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 related sections of protocols and reports associated with Pharmacokinetic (PK), Pharmacodynamic (PD), and safety studies.
• Represent CMC and provide nonclinical formulation, DS and DP stability, and supply guidance at internal and external cross functional team meetings.
• Coordinate shipments in support of nonclinical and Clinical development supply requirements to various CDMO and CRO sites.
• Assist in compiling formulation-related documentation for regulatory submissions (e.g., IND, CTA) to meet non-clinical development requirements.
• Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions.

Qualifications

• Advanced degree in Chemistry, Pharmaceutical Sciences, or a related discipline; Ph.D. is strongly preferred.
• 10+ years of drug product/formulation development experience supporting nonclinical and clinical programs, with expertise across oral, subcutaneous, and intravenous dosage forms for small molecules.
• Deep technical expertise in the development and manufacture of poorly soluble (BCS Class II/IV) compounds, including formulation strategies for oral and parenteral delivery.
• Strong understanding of pharmaceutical sciences and engineering principles related to liquid and solid dosage form development from early-stage development through clinical and commercial manufacturing.
• Working knowledge of analytical and solid-state characterization techniques, including HPLC/UPLC, XRPD, DSC, TGA, DVS, and related methodologies.
• Experience managing external development and manufacturing partners (CROs, CDMOs, and CMOs) and a solid understanding of cGMP requirements.
• Proven ability to lead multiple complex programs in a fast-paced environment, with strong project management, prioritization, resource management, and organizational skills.
• Excellent communication, presentation, and interpersonal skills, with the ability to influence stakeholders, build productive internal and external partnerships, and communicate complex scientific concepts to diverse audiences.
• Strategic, hands-on leader with strong decision-making and problem-solving capabilities, demonstrated resilience, and a track record of delivering high-quality results with urgency and integrity.
• Willing and able to travel domestically and internationally as needed.

Work Location

The Senior Director Drug Product CMC role is based in the US, with occasional travel.