Director, Late-Stage Formulation Development

Kymera Therapeutics•Watertown, MA

About The Position

The Director of Formulation Development will assist in the development of late-stage oral drug product development and commercial manufacturing strategies to support Kymera’s small molecule pipeline from Phase 2/3 through commercialization. This is an opportunity to join a fast-paced, innovative biotech environment where bold ideas and collaboration drive breakthroughs. As a member of the CMC team, you will develop and implement robust, scalable manufacturing processes for late-stage manufacturing and eventual commercialization. The ideal candidate will bring deep expertise in oral solid dose formulation development and manufacturing within a GMP environment, strong project leadership capabilities, and a passion for working in a dynamic, mission-driven culture focused on delivering life-changing medicines. This role will work cross-functionally with CMC, Regulatory, Quality and external partners to deliver high-quality drug products aligned with program timelines.

Requirements

Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or related field with 10+ years of industry experience, or M.S. with 15+ years of relevant experience.
Demonstrated expertise in late-stage small molecule formulation development and manufacturing for oral solid dosage forms.
Proven track record of advancing compounds through Phase 3, regulatory approval, process validation and commercialization.
Deep technical expertise in oral solid dosage form manufacturing and process development, spanning unit operations such as tableting, encapsulation, coating, granulation, spray drying, hot-melt extrusion, and milling.
Strong experience with CDMO oversight, technology transfer, and commercial supply management.
Working knowledge of global regulatory CMC requirements, including NDA preparation and inspection readiness.
Experience working in cross-functional CMC teams, strong knowledge of process and analytical development and a working knowledge of other areas of drug development
Excellent leadership, communication, and cross-functional influencing skills.

Responsibilities

Drive late-stage drug product activities, including registration and validation campaigns, and commercial readiness for solid oral dosage forms.
Define and execute phase-appropriate activities to support Phase 3 and NDA submissions
Oversee formulation robustness, process characterization, and control strategy development in alignment with QbD principles.
Provide technical and strategic oversight of CDMOs, including development, scale-up, technology transfer, and clinical batch production to ensure reliable supply.
Collaborate with Analytical Development to ensure late-stage method readiness, validation, and stability strategies to support shelf-life assignments.
Partner with Regulatory Affairs to author and review CMC sections for global filings, including responses to health authority questions and inspections.
Review and approve master and executed batch records. Ensure compliance with GMP requirements and lead or support deviation investigations, CAPAs, and change control processes.
Provide technical leadership in troubleshooting manufacturing issues.