Principal Scientist, Analytical Development

Principal Scientist, 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 .

• 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.

As the Principal Scientist, 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 all 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 Phase 3 clinical studies, registration, process performance qualification (PPQ), and eventual commercial manufacture
• 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 Kymera’s internal 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
• Collaborate effectively with internal and external stakeholders to deliver on program objectives
• Participate in authoring and reviewing analytical sections of late phase regulatory submissions (e.g., IND, 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

• PhD in Analytical Chemistry or related life sciences field is preferred, but not required, with 7+ years of experience in CMC analytical development
• Demonstrated late phase analytical development experience in drug substance and drug product (oral solid dosage experience required)
• 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 for DS and DP testing
• Capable of designing, implementing, and managing cGMP stability…