Director or Senior Director, CMC Program Management
Kymera Therapeutics
August 19, 2026
Remote friendly (Greater Boston)
United States
Operations
How you’ll make an impact:
- Drive end-to-end CMC program management for mid to late-stage programs, including timeline development, critical path identification, risk assessment, and execution tracking.
- Build and maintain integrated plans spanning drug substance, drug product, analytical, quality, regulatory, and supply chain workstreams.
- Support Phase 3, registration and validation campaigns, commercial-scale technology transfer, and commercial readiness for oral solid dosage forms.
- Conduct CMC team meetings; ensure clear, timely communication of status, risks, decisions, and issues.
- Participate in CDMO/CRO meetings to monitor status, action items, and risks; proactively identify items requiring action.
- Coordinate preparation, review, and on-time delivery of CMC components for global regulatory filings with Regulatory Affairs and subject matter experts.
- Serve as the CMC timeline and deliverables go-to contact for CMC function leads, core team program managers, and cross-functional partners.
- Develop CMC best practices for decision-making and scenario planning.
- Promote cross-functional collaboration and execution excellence.
Skills and experience you’ll bring:
- PhD/M.S. (or equivalent) in pharmaceutics, pharmaceutical sciences, chemistry, or chemical engineering; 10+ years (PhD) or 15+ years (M.S.) of CMC experience (Sr. Director: commensurate additional experience).
- CMC program/project management for oral small molecule programs through Phase 3, NDA/MAA submission, process validation, and approval.
- Broad CMC technical knowledge across drug substance, drug product, and analytical development.
- Experience with CDMOs/CROs, technology transfer, GMP manufacturing, and commercial supply management.
- Working knowledge of global CMC regulatory requirements (FDA/EMA/ICH), GMP/GLP compliance, and inspection readiness.
- Ability to manage complex cross-functional programs; exceptional communication, organization, and attention to detail.
- Proficiency with project management tools (e.g., MS Project, Smartsheet).
- Drive end-to-end CMC program management for mid to late-stage programs, including timeline development, critical path identification, risk assessment, and execution tracking.
- Build and maintain integrated plans spanning drug substance, drug product, analytical, quality, regulatory, and supply chain workstreams.
- Support Phase 3, registration and validation campaigns, commercial-scale technology transfer, and commercial readiness for oral solid dosage forms.
- Conduct CMC team meetings; ensure clear, timely communication of status, risks, decisions, and issues.
- Participate in CDMO/CRO meetings to monitor status, action items, and risks; proactively identify items requiring action.
- Coordinate preparation, review, and on-time delivery of CMC components for global regulatory filings with Regulatory Affairs and subject matter experts.
- Serve as the CMC timeline and deliverables go-to contact for CMC function leads, core team program managers, and cross-functional partners.
- Develop CMC best practices for decision-making and scenario planning.
- Promote cross-functional collaboration and execution excellence.
Skills and experience you’ll bring:
- PhD/M.S. (or equivalent) in pharmaceutics, pharmaceutical sciences, chemistry, or chemical engineering; 10+ years (PhD) or 15+ years (M.S.) of CMC experience (Sr. Director: commensurate additional experience).
- CMC program/project management for oral small molecule programs through Phase 3, NDA/MAA submission, process validation, and approval.
- Broad CMC technical knowledge across drug substance, drug product, and analytical development.
- Experience with CDMOs/CROs, technology transfer, GMP manufacturing, and commercial supply management.
- Working knowledge of global CMC regulatory requirements (FDA/EMA/ICH), GMP/GLP compliance, and inspection readiness.
- Ability to manage complex cross-functional programs; exceptional communication, organization, and attention to detail.
- Proficiency with project management tools (e.g., MS Project, Smartsheet).