Senior Director, CMC Program Management End-to-End

Kymera Therapeutics; City of Watertown (NY); On-site; USD 195,000 - 330,000; Full time

Job summary

Kymera Therapeutics in the United States is seeking a senior CMC program manager to lead end-to-end CMC program management for mid to late-stage programs, including timeline development, risk assessment and execution tracking.

You will build and maintain integrated plans across drug substance, product, analytical, regulatory and supply chain, and support Phase 3, NDA/MAA submissions, technology transfer and commercial readiness for oral solid dosage forms.

Qualifications

• CMC program/project management experience for oral small molecule programs through Phase 3 and NDA/MAA submission.
• Broad CMC knowledge across substance, product, and analytical development.
• Experience with CDMOs/CROs, technology transfer, GMP manufacturing, and regulatory readiness.

Responsibilities

• 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.
• Coordinate preparation, review, and on-time delivery of CMC components for global regulatory filings in partnership with Regulatory Affairs.
• Serve as the go-to contact for CMC function leads and cross-functional partners, ensuring clear communication of status, risks, and decisions.
• Develop CMC best practices for decision-making and scenario planning.

Skills

CMC program management

Cross-functional leadership

Regulatory knowledge

Project management tools

Communication skills

Education

PhD in pharmaceutics / pharmaceutical sciences / chemistry / chemical engineering

MS in related discipline

Tools

MS Project

Smartsheet

Job description

Kymera Therapeutics in the United States is seeking a senior CMC program manager to lead end-to-end CMC program management for mid to late-stage programs, including timeline development, risk assessment and execution tracking.

You will build and maintain integrated plans across drug substance, product, analytical, regulatory and supply chain, and support Phase 3, NDA/MAA submissions, technology transfer and commercial readiness for oral solid dosage forms.