Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company
(Associate) Director, Drug Product - CMC
Boston, MA · Director
Sponsorship not specifiedDetected 21 hours ago
Project ManagementSupply ChainAR/VRResearchMass Spectrometry
About the role
- The successful candidate will have a demonstrated track record of designing high performance nonclinical and clinical formulations as well as managing CROs and CDMOs.
Responsibilities
- Manage and guide external vendors, such as Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to:
- 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.
- Coordinate shipments in support of nonclinical and Clinical development supply requirements to various CDMO and CRO sites.
Requirements
- 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, XR
Nice to have
- Execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs).
- 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.
- 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.
- BS or MS in Pharmaceutical Sciences or a related scientific discipline required
- PhD strongly preferred.
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