Director Formulation and CMC
Meet Life Sciences, San Diego, CA, United States
Associate Director/Director, CMC (Drug Product & Combination Products)
Must have experience with biologics and liquid formulation!
Overview
The Associate Director/Director of CMC will lead drug product strategy and development activities to support delivery of existing drug molecules through a novel ingestible drug-device platform. This role oversees phase-appropriate formulation development, ensuring compatibility with device components, sterilization, and stability requirements for drug-device combination products. The position also manages external partners and supports regulatory submissions and clinical readiness.
Key Responsibilities
Formulation Development
- Lead formulation optimization for molecules intended for delivery via an ingestible device platform.
- Design and execute formulation, stability, and degradation studies to support drug-device combination product performance and robustness.
Drug–Device Integration
- Assess compatibility between formulations, device materials, and release mechanisms.
- Partner with engineering teams to support manufacturability and integration with device assembly and fill-finish processes.
- Resolve formulation and device interface challenges to ensure consistent product performance.
External Manufacturing & CMC Execution
- Oversee CDMO strategy and management for formulation development, analytical activities, and GMP manufacturing.
- Lead technology transfer, batch execution, and resolution of deviations and change controls.
- Develop and manage integrated CMC plans including timelines, budgets, and supply forecasting.
Quality, Regulatory & Cross-Functional Collaboration
- Ensure compliance with GMP/GxP requirements and applicable quality standards.
- Contribute to CMC sections of regulatory filings.
- Collaborate cross-functionally with preclinical, program management, and quality teams to support development milestones.
Qualifications
Requirements
- PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related discipline preferred; MS with significant experience considered.
- ~8-12 years of experience in formulation, drug product development, or related CMC functions.
- Demonstrated success transferring processes to CDMOs and delivering GMP clinical supplies.
- Strong knowledge of formulation science, stability, and control strategies.
- Experience managing external partners and development programs in fast-paced biotech environments.