Associate 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. For more information about our science, pipeline and people, please visit  or follow us on X (formerly Twitter) or Linked In. 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:

As the Associate Director, Analytical Development, you will contribute to CMC activities supporting mid and late phase clinical development of Kymera’s small-molecule protein degraders. You will use your scientific expertise to support CMC analytical development activities, in partnership with CDMOs.Execute development and validation of critical analytical methods, including achiral and chiral HPLC, GC, IC, dissolution, and methods for quantification of potentially mutagenic impurities (PMIs) and nitrosamine impurities

Ensure analytical methods, control strategies, and specifications are robust and validated to support late stage activities from Phase 3 to commercial readiness

Partner with CMC scientist to understand and characterize drug substance and drug product-related impurities, including impurity formation and purging, and critically review analytical testing results

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 Kymera’s internal lab Partner closely with CMC colleagues and QA to prepare and review GMP documentation, analytical data and technical reports, and  support investigation of nonconformances (OOS/OOT results, deviations, etc.)Participate in authoring and reviewing analytical sections of late phase regulatory submissions (e.g., IND, IMPD, NDA, MAA).Support health authority interactions, including responses to agency questions related to analytical methods and controls.

Ensure analytical approaches meet global regulatory expectations and inspection readiness standards

Skills and experience you’ll bring:

PhD in Analytical Chemistry or related life sciences field is preferred, but not required, with 10+ years of experience in CMC analytical development of small molecule drug substance and oral solid dosage forms

Experience in developing impurity control strategies, including potentially mutagenic impurities (PMIs) and nitrosamine impurities

In-depth expertise in late phase test method development, method validation/transfer, and characterization of small-molecule drugs

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…