Assoc Director/Director of Process Development - Drug Substance

Associate Director/Director, Process Development/Drug Substance

Programmable Medicine is a pre-revenue, clinical-stage biotechnology company focused on discovering and developing innovative therapies for patients with serious diseases. The company operates across multiple legal entities and partners with external CROs, CMOs, and research institutions globally. Backed by leading venture capital investors, Programmable Medicine is building a scalable finance function to support rapid growth and pipeline advancement.

We are looking for a dynamic and experienced Associate Director/Director, Process Development/Drug Substance to guide late-stage development and ensure adequate supply for launch/commercialization. This newly created role requires a leader with deep understanding of CMC principles, manufacturing, regulatory requirements, and a proven track record of success in guiding late-stage candidates through development. The candidate will engage with internal Med Chem and CDMO(s) for process development, scale up that enables robust production of Drug Substance (DS) and payload for dendrimer-based drug candidates. This is a hands-on individual contributor position located at our Redwood City facility. Candidates must be able to work on site 3 days per week.

Key Responsibilities

• Build development strategy to advance clinical assets from Phase 2 through launch and commercialization
• Develop phase-appropriate product understanding and control strategies using QbD framework
• Lead risk assessments and integrate output into QbD-based development study
• Support manufacture of clinical GMP DS and payload throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
• Review/approve master and execute batch records, support investigations, and resolve deviations
• Analyze process and manufacturing data to understand and optimize process performance
• Author and support regulatory submissions (IND, IMPD, amendments)
• Improve production models that enable granular connectivity with clinical supply
• Develop cost of good models that describe process and enable sensitivity analyses for process improvements
• Guide the organization in improving business processes to support effective CMC management and communication
• Collaborate closely with colleagues including Med Chem, and Analytical R&D to support all process development activities of all programs
• Author and review internal procedures, reports, and presentations
• Significant contributor to defining goals and strategic vision for the TechOps organization

Requirements

• PhD in relevant discipline (e.g., chemistry, chemical engineering, or relevant field)
• At the Director level, 15+ years process development and manufacturing experience is required. Candidates with less experience may be considered but at a lower level position.
• Well-developed understanding of drug development, including collaborating with Chemistry, Analytical R&D, CDMOs, and commercial organizations.
• Experience with late-stage development and commercialization of small molecules, payloads, and dendrimers is needed.
• Demonstrated ability in collaborating strategically with various functional areas including analytical development, Manufacturing, QA, RA, and Supply Chain.
• Substantial experience leading Tech Transfer to CDMOs and supporting DS campaigns
• Excellent communication skills with an ability to interact effectively with stakeholders and partners
• Ability to multi-task and keep pace with a fast-moving organization
• Availability to take part in calls across multiple international time zones
• Ability and willingness to travel
• Must be able to work 3 full days on site at our Redwood City facility.

What we can offer you

This is a unique opportunity to join a team focused on a new class of precision medicines that selectively treat diseased cells in regions of inflammation. By making precision medicine even more precise, our nanomedicine technology has the potential to change the standard of care across ophthalmology, neurology, inflammatory diseases and neuro-oncology.

We have a comprehensive total compensation package including fully paid medical, dental, and vision benefits for you and your family. The Company also offers participation in the annual bonus program. The salary range for PhD, Director level candidates located in the Bay Area is $185,000 - $230,000 annually. We consider various factors when determining the base compensation, including market survey data, experience, qualifications, which means the actual compensation may vary. Candidate's who do not meet the requirements for a Director level position, may be considered for an Associate Director level role at a lower base salary.