Associate Director, Analytical Development

Kymera Therapeutics•Watertown, MA

9d•$160,000 - $240,000

About The Position

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.

Requirements

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 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
Experience working cross-functionally among project teams, including internal groups and external CDMOs
Scientific curiosity, problem-solving mindset, highly organized and detail-oriented, and excellent oral and written communication skills

Nice To Haves

Prior experience writing analytical sections in NDA/MAA filings a plus

Responsibilities

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