Director, Product Quality

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 will act as a Quality subject matter expert for Good Manufacturing Practices (GMP) activities. The individual will be responsible for material disposition; will provide Quality oversight for technical transfers, stability assessments, manufacturing, analytical and distribution activities performed at external suppliers. In addition, the individual will ensure compliance with regulations and Kymera policies and procedures. Provide quality oversight of contract organizations associated with the manufacturing and distribution of Drug Substances, Drug Products, and Finished Goods. Collaborate with manufacturing and distribution colleagues to (i) review manufacturing batch records, protocols, reports, and specifications, and (ii) perform disposition of critical intermediates, drug substances/drug products, and finished goods. Partner closely with CMC analytical colleagues to (i) review test methods, SOPs, analytical data summaries, validation and stability protocols, and technical reports (ii) oversee specification control and shelf life management. Ensure that product quality-related issues, including deviations/OOSs/OOTs and product complaints, are appropriately investigated and resolved. Collaborate cross-functionally and develop strong relationships with internal and external partners. Support the preparation and review of regulatory filing submissions (IND/IMPD/NDA) Help develop and implement phase-appropriate SOPs and policies. Ensure compliance with relevant regulatory requirements such as FDA, EMA, and ICH guidelines. Manage the qualification and performance monitoring of external GMP suppliers and maintain Quality Agreements with them. Develop and track quality metrics to measure performance and identify trends. Present quality assessments to the Material Review Board and Quality Management Review Board. Provide support for late-stage manufacturing and commercialization readiness activities. Skills and experience you’ll bring: 8 + years of experience in pharmaceutical manufacturing or laboratory settings, including at least 4 years in a GMP quality assurance role. Experience in a small-molecule manufacturing environment is preferred. Experience providing Quality oversight of outsourced late-phase GMP manufacturing activities, including process validation and commercial readiness. Excellent communication and interpersonal skills. Experience working in a CMC team setting as a Quality representative. Work independently and manage multiple projects within the established timelines and objectives. Strong problem-solving ability to evaluate quality matters and make risk-based decisions. Equal Employment Opportunity Kymera The