About this role
Kymera is a clinical-stage biotechnology company pioneering targeted protein degradation (TPD) to address critical health problems with innovative medicines. As Associate Director of Drug Substance Development, you serve as the accountable Drug Substance lead for one or more programs. You own DS strategy, execution, and delivery from late discovery through clinical development.
Use scientific, data-driven, and risk-based approaches to clinical and commercial route and process innovation, guided by safety and green chemistry principles. Provide technical leadership and decision-making oversight for outsourced Drug Substance development at CROs and CDMOs. Ensure quality, timelines, and scientific rigor in all activities.
Serve as Drug Substance technology lead for internal and external knowledge transfers, authoring strategies and defining success criteria. Collaborate with Drug Product and Analytical colleagues to control physical attributes for manufacturing. Work effectively with stakeholders to meet program objectives in a trust-based environment.
Join a team that values PIONEER, COLLABORATE, and BELONG principles, fostering courage, transparency, and inclusivity. Contribute to an industry-leading pipeline of oral small molecule degraders. Kymera has been recognized as one of Boston’s top workplaces for several years.
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 bringing small molecule assets from late discovery through mid-phase clinical trials
- Experience serving as the Drug Substance lead on fully integrated Chemistry, Manufacturing, and Control (CMC) teams
- Experience directing CRO and CDMO partners
- Experience writing and reviewing Drug Substance related technical documents
- Deep understanding of small molecule drug development and how CMC disciplines integrate with Quality, Non-clinical Safety, Clinical, Regulatory, and Intellectual Property Protection
- In-depth familiarity with phase based GMPs
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-driven, 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 and defining success criteria
- Collaborate with Drug Product and Analytical colleagues to ensure Drug Substance physical attributes are understood, controlled, and 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
Benefits
- Recognized as one of Boston’s top workplaces for the past several years
- PIONEER: courageous, resilient and rigorous mission to improve patients’ lives through revolutionary degrader medicines
- COLLABORATE: value trust + transparency, shared goals, data-driven decisions, genuine camaraderie
- BELONG: recognize differences, inviting curiosity and inclusivity so people are valued, seen, and heard
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