Associate Director, Analytical Development

Kymera Therapeutics - Watertown, MA

Full-time - Senior

Watertown, MA

Professional, Scientific, and Technical Services

About the position

As the Associate 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.

Responsibilities

• Lead analytical activities for development projects and collaborate with Process Chemistry and Formulation Development teams
• 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 write or review test methods, SOPs, analytical data summaries (CoT/CoA), protocols, and technical reports
• Critically review, trend, and interpret analytical testing results
• 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

Requirements

• PhD in Analytical Chemistry or related life sciences field is preferred, but not required
• 7+ 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 analytical 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