Associate Director, Drug Product - CMC

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company•Boston, MA

2d•$140,000 - $195,000•Hybrid

About The Position

Centessa Pharmaceuticals is seeking an Associate Director of Drug Product within the CMC group to support early-stage programs. The successful candidate will have a proven track record in designing high-performance nonclinical and clinical formulations and managing CROs and CDMOs. This role involves hands-on experience in developing and manufacturing small molecule drug products for Phase I to Phase III clinical trials. The primary focus will be leading vendor work and overseeing nonclinical formulation development, with flexibility to support clinical drug product development across programs to meet company deliverables and timelines. Occasional domestic and international travel to vendor sites may be required.

Requirements

BS or MS in Pharmaceutical Sciences or a related scientific discipline required; PhD strongly preferred.
10+ years of experience in small molecule formulation development, including support of 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 for oral, subcutaneous, and intravenous delivery.
Strong knowledge of pharmaceutical and engineering principles related to liquid and solid dosage form development at clinical and commercial scale.
Proficiency with analytical and solid-state characterization techniques, including 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, develop contingency plans, and drive timely, high-quality results.
Excellent communication, interpersonal, and project leadership skills, with the ability to influence stakeholders, manage cross-functional and external relationships, and effectively communicate complex concepts to diverse audiences.
Highly organized, detail-oriented, and self-directed, with the ability to manage multiple priorities and perform effectively in a fast-paced, dynamic environment.
Willingness to travel domestically and internationally (5-10%).

Responsibilities

Manage and guide external vendors (CROs and CDMOs) to execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs).
Design and develop nonclinical formulations (oral, subcutaneous, and intravenous) ensuring 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 for Pharmacokinetic (PK), Pharmacodynamic (PD), and safety studies.
Represent CMC and provide guidance on nonclinical formulation, DS and DP stability, and supply at internal and external cross-functional team meetings.
Coordinate shipments for 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 nonclinical development requirements.
Collaborate closely with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality, and regulatory, as well as other CMC functions.