Analytical Development Associate Director - 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 www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. 

How we work:

• 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.

How you’ll make an impact:

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.

• 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

Skills and experience you’ll bring:

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

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, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation

• 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 $160,000 – $240,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.