(Associate) Director, Drug Product - CMC

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

1d•$170,000 - $195,000•Onsite

About The Position

Centessa’s CMC group is currently seeking an (Associate) Director of Drug Product within the CMC group to support our early stage programs. The successful candidate will have a demonstrated track record of designing high performance nonclinical and clinical formulations as well as managing CROs and CDMOs. The candidate should also have hands-on experience in developing and manufacturing nonclinical and clinical small molecule drug products to support Phase I to Phase III. This candidate will primarily lead work with various vendors and oversee nonclinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines. Travel to vendors both domestically and internationally might occasionally 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, 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 nonclinical 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.