Director or Senior Director, CMC Program Management

Who we are

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.

Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please  or follow us onX (formerly Twitter) orLinked

In.

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.

Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please  or follow us onX (formerly Twitter) orLinked

In.

• PIONEER:
  We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE:
  We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG:
  We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

• 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 work streams.
• Support planning and execution of Phase 3, registration and validation campaigns, commercial-scale technology transfer, and commercial readiness activities 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, and ensure alignment with CMC plans. Proactively identify items that require action.
• Coordinate preparation, review, and on-time delivery of CMC components for global regulatory filings, in partnership 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 a culture of cross-functional collaboration and execution excellence.

• PhD., M.S., or equivalent in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or a related discipline, with 10+ years (Ph.D.) or 15+ years (M.S.) of CMC experience;
  Sr. Director level requires commensurate additional experience and demonstrated scope.
• CMC program/project management experience for oral small molecule programs, with experience advancing programs through Phase 3, NDA/MAA submission, process validation, and approval.
• Broad CMC technical knowledge spanning drug substance, drug product, and analytical development, with sufficient depth to challenge assumptions, assess risk, and support troubleshooting.
• Prior experience in working with CDMOs and CROs, technology transfer, GMP manufacturing, and commercial supply management.
• Working knowledge/experience in…