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Centessa's CMC group is seeking an Associate Director of Drug Product to lead formulation development for early-stage small molecule programs, with a focus on neurological indications such as narcolepsy.
The role oversees nonclinical and clinical formulation, manages CROs/CDMOs, guides physiochemical characterization, pre-formulation, stability, and compatibility studies, and collaborates with discovery, nonclinical, clinical, and regulatory teams.
Role: Associate Director of Drug Product within Centessa's CMC group, supporting early-stage small molecule programs, particularly for neurological indications like narcolepsy.
Responsibilities: oversee nonclinical and clinical formulation development, manage CROs/CDMOs, guide physiochemical characterization, pre-formulation, stability, and compatibility studies; support clinical formulation efforts; author and review development documentation; coordinate shipments and regulatory submissions; collaborate with cross-functional teams (discovery, nonclinical, clinical, regulatory).
Requirements: BS/MS in Pharmaceutical Sciences or related; PhD preferred; 10+ years in small molecule formulation development supporting Phase I-III; expertise in poorly soluble (BCS II/IV) compounds, liquid and solid dosage forms, analytical techniques (HPLC, XRPD, DSC, TGA, DVS); experience managing external vendors and working within cGMP standards.
HighValue: small molecule drugs, neurological indications (narcolepsy, hypersomnia), Phase I-III, nonclinical and clinical formulation, cGMP, vendor oversight.
WorkSetup: based in US, with occasional domestic/international travel (5-10%).