We are seeking an Associate Director to join our team at Kymera Therapeutics. Reporting to the Senior Director, Analytical Development, this candidate will advance pharmaceutical development projects by providing hands-on technical leadership, strategic guidance, and data analyses throughout the IND-enabling and clinical development stages of Kymera's small-molecule protein degraders. This individual will use their leadership and scientific expertise to support all CMC analytical development activities to help grow our pipeline, and aid in the partnership with CDMOs.

Kymera Therapeutics is a publicly listed, clinical stage biotechnology company pioneering the field of targeted protein degradation (TPD) to bring life-changing medicines to patients that need them. Kymera's Pegasus™ TPD platform harnesses the body's natural protein recycling machinery to degrade disease-causing proteins, with a focus on undrugged nodes in validated pathways currently inaccessible with conventional therapeutics. As we work toward becoming a fully-integrated biopharmaceutical company, we are growing and strengthening organizational capabilities and evolving our culture. As a result, Kymera has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston's top workplaces.

In 2023, we plan to continue to advance our leadership in TPD and enhance our capabilities to deliver on the potential of inventing a new class of protein degrader medicines for patients. Kymera is rapidly advancing four clinical stage programs in oncology and immunology, and is positioned to deliver one additional Investigational New Drug Applications (IND) annually. We are also actively advancing a broad pipeline of preclinical programs where TPD has the potential to provide a best-in-class approach, both internally and in collaboration with our partners Sanofi and Vertex Pharmaceuticals.

Responsibilities:

• Provide technical leadership for all CMC analytical activities, including specification setting, test method development and qualification, and outsourced QC testing for drug substance and drug product
• Lead cross-functional collaborations to establish phase-appropriate specifications and analytical control strategies for starting materials, intermediates, drug substance, excipients, and drug product
• Lead the characterization of DS and process and product-related impurities, including analytical oversight for solid-state characterization studies
• Accountable for design, development, and phase-appropriate validation of critical test methodologies, including chiral and achiral HPLC, GC, IC, in-vitro dissolution, and techniques for quantification of potential mutagenic impurities (PMIs)
• Establish and maintain outsourced ICH stability programs for drug substance and drug product
• Prepare/review request-for-proposals (RFP) and manage day-to-day analytical development and testing activities at CDMOs and contract test labs to assure that projects remain on-track
• 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 (ii) 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

Qualifications:

• PhD in analytical chemistry (preferred), organic chemistry, or a related life sciences field with 7+ years of experience in CMC analytical development
• Demonstrated analytical development experience in both drug substance and drug product (oral and parenteral), including establishment of specifications and analytical control strategies for starting materials, intermediates, and final products
• Experience developing impurity control strategies, including for potentially mutagenic impurities (PMIs)
• In-depth expertise in test method development, method qualification/transfer, and characterization of small-molecule drugs during preclinical (GLP toxicology) and early-phase clinical development
• Chiral HPLC method development and qualification experience
• 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 test 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
• Problem-solving and troubleshooting skills
• Demonstrated leadership, planning and organizational skills
• Extensive experience providing technical leadership to CDMOs and contract test lab partners
• Experience with working cross-functionally among project teams, including internal groups and external CDMOs
• Exceptional oral and written communication skills geared to all levels of the organization
• Proficiency with MS Office and document sharing and archival platforms

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.