Director, Analytical Development

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. 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 contribute: As the Director, Analytical Development, you will help advance pharmaceutical development projects throughout the IND-enabling and clinical development stages of Kymera's small-molecule protein degraders. You will use your leadership and scientific expertise to support all CMC analytical development activities to help grow our pipeline, and aid in the partnership with CDMOs. Serve as an Analytical Development lead and develop small molecule analytical control strategies, specifications, methods, and stability studies for both drug substance and drug product Collaborate with Process Chemistry and Formulation Development teams to design in-process control methods and impurity control strategies Develop a method development platform to address unique challenges in testing methods for heterobifunctional small molecule drug candidates for Target Protein Degradation (TPD) Accountable for phase-appropriate development and validation of critical test methodologies, including achiral and chiral HPLC, GC, IC, in-vitro dissolution, and methods for quantification of potential mutagenic impurities (PMIs) and Nitrosamine impurities Characterize drug substance and drug product-related impurities Design and monitor ICH stability programs for drug substance and drug product Manage day-to-day analytical development and testing activities at CDMOs and contract test labs to ensure that projects remain on track Contribute to implementing and operating analytical capabilities in a new state-of-the-art lab Partner closely with CMC colleagues and QA to (i) write or review test methods, SOPs, analytical data summaries (CoT/CoA), protocols, and technical reports, (ii) critically review, trend, and interpret analytical testing results, and (iii) support investigation of nonconformances (OOS/OOT results, deviations, etc.) Communicate and present analytical data in CMC meetings and other cross-functional settings Author CMC analytical sections in INDs and other regulatory filings Collaborate effectively with internal and external stakeholders to deliver on program objectives Skills and experience you'll bring: PhD in Analytical Chemistry or related life sciences field is preferred, but not required 10 years of experience in small molecule CMC analytical development Strong problem-solving and troubleshooting skills Demonstrated leadership, planning and organizational skills Excellent oral and written communication skills geared to all levels of the organization Demonstrated analytical development experience in small molecule drug substance and/or drug product (oral, or parenteral, etc) Experience in developing impurity control strategies, including for potentially mutagenic impurities (PMIs) and nitrosamine impurities a plus In-depth expertise in test method development, method qualification/ transfer, and characterization of small-molecule drugs during all phases of clinical development Broad analytics expertise with widely employed techniques - HPLC (UV, RID, ELSD, CAD), GC, MS, NMR, XRPD, DSC/TGA, KF, particle size analysis, and dissolution Knowledgeable of compendial testing methods (USP/EP) used for DS and DP testing Capable of designing, implementing, and managing cGMP stability studies for DS and DP at external labs Strong working knowledge of GLP, cGMP, and ICH requirements Prior experience writing analytical sections in IND/IMPD filings a plus Experience providing technical guidance to CDMOs and contract test labs Experience working cross-functionally among project teams, including internal groups and external CDMOs Skills and experience not an exact match?: Go ahead and submit your resume (and a cover letter, if you'd like). If this role isn't right for you, we can keep you in mind for future opportunities. 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.