Associate Director, Process Chemistry

Who we are:

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 contribute:

• Provide creative and strategic innovation, oversight, and leadership on small molecule drug development activities including route scouting, process development, candidate scale-up, technology transfer, and clinical stage manufacturing.
• Create scientific plans that include process development strategies that translate into deliverables and milestones in a constantly evolving work environment. Develop contingency plans where necessary.
• Apply fundamental chemistry and engineering principles to solve synthesis, analytical, process design, production equipment, and regulatory challenges.
• Partner with Discovery Chemistry to facilitate efficient candidate nomination into development.
• Design manufacturing processes that are safe, scalable, robust, cost effective, and environmentally friendly.
• Apply industry best practices to address complex issues involving salt, polymorph and particle size attributes, synthesis, reaction kinetics, process safety, analytics, impurity profile management, bioavailability, processibility, stability, and equipment design.
• Identify critical material attributes and the design space necessary to ensure process robustness in the scale-up and manufacture of development, clinical, registration stability, and process validation batches.
• Analyze and summarize complex data sets. Prepare technical reports, publications, and oral presentations.
• Assist in the writing and review of CMC regulatory submissions.
• Work with cross-functional program teams providing budgets, updates, and project management support required to achieve pre-clinical and clinical development goals and timelines.
• Establish strong and effective communication/collaboration with internal and external development partners.
• Communicate risks and delays to line management/project teams in a timely way.
• Travel domestically and/or internationally to accomplish objectives, when necessary.

What skills and experience you’ll bring:

• Ph.D. in Chemistry with 8-10 years’ experience, or M.S. in Chemistry with 10-15 years in Drug Substance Development.
• Experience with drug development challenges such as route scouting and selection, methodology development, process development, process safety, material characterization, and quality-by-design principles.
• Strong laboratory skills and knowledge of organic synthesis and pharmaceutical development. Proficient in the use and interpretation of modern analytical techniques, e.g. HPLC, MS, GC, NMR, KF, DSC, TGA, XRD, photo-microscopy, particle attribute characterization, calorimetry, and process automation platforms.
• Experience working in various environments, including research laboratory, kilo lab, and pilot scale facilities.
• Experience working in a GMP environment and with quality assurance organizations.
• Knowledge of basic chemical engineering principles and how they apply to small molecule development.
• Working knowledge of ICH Guidelines and how they impact drug substance development.
• Experience in working with and managing CRO and CDMO partners.
• Ability to serve on CMC teams.
• General understanding of small molecule drug development and knowledge of or willingness to learn how CMC disciplines integrate and partners with functional areas such as Risk Management and Quality, Drug Safety, Clinical, Regulatory, Intellectual Property Protection, and Contracts.
• Willingness and ability to work hands-on and with a sense of urgency in a fast-paced, agile environment.
• Ability to manage ambiguity, think critically, and make sound scientific and business decisions when there is limited information. Ability to conduct, manage, and communicate risk assessments.
• Experience in contributing to regulatory submissions.
• Passion about learning and developing to help build a dynamically growing company at the cutting edge of Targeted Protein Degradation.

Skills and experience not an exact match?:

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.