Principal Scientist, Analytical Development

Kymera Therapeutics • Watertown, MA

3h • $145,000 - $215,000

About The Position

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.

Requirements

• 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 studies for DS and DP at external labs
• Strong working knowledge of GLP, cGMP, and ICH requirements
• 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
• Experience providing technical guidance to CDMOs and contract test labs
• Experience working cross-functionally among project teams, including internal groups and external CDMOs

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 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

Benefits

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $145,000 – $215,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree