Associate Director, Process Chemistry

Kymera Therapeutics • Watertown, MA

3d • $160,000 - $240,000

About The Position

As an Associate Director of Drug Substance Development, you will serve as the accountable Drug Substance lead for one or more development programs, owning DS strategy, execution, and delivery from late discovery through clinical development.
Use scientific, data-drive, and risk-based approaches to clinical and commercial route and process innovation and development, guided by safety and green chemistry principles.
Provide technical leadership and decision‑making oversight for outsourced Drug Substance development activities at CROs and CDMOs, ensuring quality, timelines, and scientific rigor.
Serve as the Drug Substance technology lead for internal and external knowledge transfers, including authoring transfer strategies, defining success criteria, and supporting manufacturing execution.
Collaborate with Drug Product and Analytical colleagues to ensure the Drug Substance physical attributes are understood, controlled, and are appropriate for Drug Product manufacturing.
Ensure stage appropriate data is generated and documented; serve as contributing author and technical reviewer of Drug Substance sections of regulatory filings.
Collaborate effectively with internal and external stakeholders to deliver on program objectives.

Requirements

• Ph.D. in Chemistry or Chemical Engineering with at least 7 years’ or B.S./ M.S. in Chemistry or Chemical Engineering with at least 12 years’ experience in Drug Substance Development.
• Experience with: Bringing small molecule assets from late discovery through mid-phase clinical trials.
• Serving as the Drug Substance lead on fully integrated Chemistry, Manufacturing, and Control (CMC) teams.
• Directing CRO and CDMO partners.
• Writing and reviewing Drug Substance related technical documents.
• Deep understanding of small molecule drug development; understand how CMC disciplines integrate and partner with associated functional areas such as Quality, Non-clinical Safety, Clinical, Regulatory, and Intellectual Property Protection.
• In-depth familiarity with phase based GMPs and manufacturing compliance requirements, regulatory guidelines and expectations.
• Willingness and ability to work hands-on and with a sense of urgency in a fast-paced, agile environment.
• Demonstrated ability to make sound, risk‑based scientific and business decisions in ambiguous, fast‑paced development environments.
• Ability to conduct, manage, and communicate risk assessments.

Nice To Haves

• Ability to develop data driven crystallization processes based on an understanding and application of fundamental principles.
• Experience using statistical and modelling software applicable to Drug Substance Development and Manufacturing to support process understanding and decision making.
• Design and execution of process characterization with cross-functional colleagues, utilizing Quality by Design principles.
• Comfortable stepping into hands‑on problem solving when needed to unblock programs, while maintaining focus on strategic and technical leadership.

Responsibilities

• Serve as the accountable Drug Substance lead for one or more development programs, owning DS strategy, execution, and delivery from late discovery through clinical development.
• Use scientific, data-drive, and risk-based approaches to clinical and commercial route and process innovation and development, guided by safety and green chemistry principles.
• Provide technical leadership and decision‑making oversight for outsourced Drug Substance development activities at CROs and CDMOs, ensuring quality, timelines, and scientific rigor.
• Serve as the Drug Substance technology lead for internal and external knowledge transfers, including authoring transfer strategies, defining success criteria, and supporting manufacturing execution.
• Collaborate with Drug Product and Analytical colleagues to ensure the Drug Substance physical attributes are understood, controlled, and are appropriate for Drug Product manufacturing.
• Ensure stage appropriate data is generated and documented; serve as contributing author and technical reviewer of Drug Substance sections of regulatory filings.
• Collaborate effectively with internal and external stakeholders to deliver on program objectives.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees