Senior Manager / Associate Director, Process Development

Senior Manager / Associate Director, Process Development

Department: CMC

Work Location: This is an on-site position based at our corporate Headquarters in South San Francisco, CA.

Position Summary: TCG Labs Soleil is seeking a highly organized and experienced biologics CMC professional to join our CMC team as Senior Manager / Associate Director, Process Development. Reporting to the Senior Director, CMC Lead, this individual will help drive day-to-day execution of our expanding portfolio of CMC development programs. This role is ideal for someone who combines deep technical expertise in biologics drug substance or drug product process development/manufacturing with strong CMC project management skills. In this role you will be working closely with CDMOs and internal partners and will be responsible for providing technical oversight to ensure on-time delivery of clinical materials. The position offers significant growth opportunities in a fast-paced and highly collaborative startup environment.

Responsibilities:

Technical Leadership

• Serve as key technical owner for at least one CMC functional area, either biologics drug substance (DS) or biologics drug product (DP) process development/manufacturing.
• Candidates with DS background will lead downstream and/or upstream process development, scale-up, technology transfer, GMP drug substance manufacturing.
• Candidates with DP background will lead formulation and drug-product manufacturing process development, aseptic fill-finish, lyophilization, clinical in-use studies and clinical supply.
• Review technical documentation, including development reports, tech transfer protocols, SOPs, master and executed batch records. Support review of deviations, investigations, CAPAs, change controls, and root-cause analyses.
• Support CMC regulatory submissions by reviewing or contributing to relevant IND/IMPD Module 3 sections.
• Work closely with Quality Assurance and Regulatory Affairs to ensure CMC documentation, batch disposition readiness, and submission deliverables meet program, quality, and regulatory expectations.

CMC Operations

• Manage day-to-day CMC operations, serving as the central coordinator across CMC, Quality Assurance, Regulatory Affairs, non-clinical, Clinical Operations, and external CDMO partners.
• Develop, maintain, and drive integrated CMC project plans, GMP manufacturing timelines, process development and technology transfer deliverables, analytical and stability deliverables, QA review cycles, regulatory submission milestones, and clinical supply needs.
• Facilitate CMC team meetings, including agenda preparation, meeting minutes, action tracking, decision documentation, and communication of key updates.
• Track CMC budgets, CDMO invoices, purchase orders (PO), expenses and coordinate with finance team.
• Maintain internal CMC databases and risk registers, prepare project updates and organize critical documents.
• Drive alignment across key cross-functional milestones, ensuring manufacturing schedules, QA batch release timelines, regulatory submission needs, and clinical supply requirements are coordinated and visible.