Senior CMC Program Director - Drive Phase 3 & NDA Readiness

Kymera Therapeutics, Inc.; Watertown (MA); On-site; USD 195,000 - 330,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Comprehensive benefits

Job summary

Kymera Therapeutics, Inc. is seeking an experienced CMC Program Manager to lead end-to-end management for mid-to-late-stage programs, coordinating across drug substance, product, analytics, quality, and regulatory teams.

The role requires extensive CMC knowledge, CDMO/CRO collaboration, and strong communication skills to drive Phase 3 activities, regulatory submissions, and tech transfer for oral solid dosage forms.

Qualifications

• Requires D., M.S., or equivalent with 10+ years (Ph.D.) or 15+ years (M.S.) in CMC.
• Experience managing oral small molecule programs through Phase 3 and NDA/MAA submission.

Responsibilities

• Lead end-to-end CMC program management for mid to late-stage programs.
• Build and maintain integrated plans across drug substance, drug product, analytical, quality, regulatory, and supply chain.
• Support Phase 3, regulatory filings, and commercial-scale tech transfer.

Skills

CMC program mgmt

Cross-functional leadership

Regulatory knowledge

CDMOs/CROs experience

Communication skills

Project management tools

Education

Pharmaceutics/pharmaceutical sciences

CMC leadership experience

Tools

MS Project

Smartsheet

Job description

Kymera Therapeutics, Inc. is seeking an experienced CMC Program Manager to lead end-to-end management for mid-to-late-stage programs, coordinating across drug substance, product, analytics, quality, and regulatory teams.

The role requires extensive CMC knowledge, CDMO/CRO collaboration, and strong communication skills to drive Phase 3 activities, regulatory submissions, and tech transfer for oral solid dosage forms.