Director, CMC (Drug Product & Combination Products)
Location: San Diego, CA (Stealth/Confidential Site)

Position Type: Full-time, Permanent

About the Opportunity
Our client is a clinical-stage biotechnology company located in San Diego, developing a revolutionary ingestible device platform designed to deliver therapeutic molecules. They are bridging the gap between advanced engineering and pharmaceutical sciences to transform patient care. 
We are seeking a Director of CMC to lead drug product strategy and development activities, ensuring their therapeutic molecules are successfully adapted for delivery via their novel ingestible device platform. This is a critical leadership role responsible for bridging drug formulation with device engineering to deliver high-quality, stable, and effective combination products for clinical and tox readiness. 
Key Responsibilities

• Formulation Optimization & Device Integration:
  • Lead formulation optimization for existing small-molecule/biologic drugs, adapting them for internal jet injection via a novel ingestible device.
  • Oversee comprehensive formulation, stability, and forced-degradation studies, ensuring compatibility with device materials, sterilization, and assembly.
  • Troubleshoot formulation–device interface challenges and collaborate with engineering for seamless fill-finish integration.
• External Manufacturing & CMC Strategy:
  • Develop and manage the CDMO strategy for formulation, analytical development, and GMP manufacturing.
  • Manage technology transfer, batch execution, and resolution of deviations and change controls.
  • Own the integrated CMC plans, encompassing timelines, budgets, risk management, and supply forecasting.
• Regulatory & Quality Leadership:
  • Prepare and review CMC sections of regulatory submissions (IND/IMPD) for combination products.
  • Ensure strict compliance with GMP/GxP requirements and align with ISO standards/Quality Agreements.
• Cross-Functional Team Leadership:
  • Lead, mentor, and build a high-performing CMC team.
  • Partner with preclinical, regulatory, and program management to meet accelerated milestones. 

• Education: PhD in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Chemistry, or related field preferred; MS with extensive relevant experience considered.
• Experience: 15+ years in formulation development, drug product development, or CMC functions within the biotech/pharma industry.
• Technical Expertise: Deep understanding of small-molecule and/or biologic formulation principles, stability mechanisms, and control strategies. Hands-on experience with device-enabled delivery or oral drug delivery.
• Proven Track Record: Demonstrated success in transferring formulations to CDMOs, managing CMC activities for drug-device combinations, and supporting clinical readiness.
• Leadership & Skills: Proven ability to lead external partners, manage complex development timelines, and drive results in a fast-paced environment. Excellent problem-solving, communication, and organizational skills.