Director, Late-Stage Formulation Development

Director, Late-Stage Formulation Development Kymera Therapeutics Watertown, MA Job Details $195,000 - $275,000 a year 2 hours ago Qualifications Cross-functional collaboration Cross-functional communication Full Job Description 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 visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.

How we work:

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. How you'll make an impact: 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. 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. Skills and experience you'll bring: 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. Equal Employment Opportunity Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class. Compensation Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay. The anticipated base salary range for this role is $195,000 - $275,000, with eligibility for annual bonus, equity participation, and comprehensive benefits. Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate's depth of experience and the capabilities they bring to the position.