Associate Director, Process Chemistry
Kymera Therapeutics
2 months ago
Remote friendly (Greater Boston)
United States
Clinical Research and Development
How you’ll make an impact:
- Serve as the accountable Drug Substance lead for one or more development programs; own Drug Substance (DS) strategy, execution, and delivery from late discovery through clinical development.
- Use scientific, data-driven, and risk-based approaches to clinical and commercial route/process innovation and development, guided by safety and green chemistry principles.
- Provide technical leadership and oversight for outsourced DS development at CROs and CDMOs, ensuring quality, timelines, and scientific rigor.
- Lead DS technology for internal/external knowledge transfers (author transfer strategies, define success criteria, support manufacturing execution).
- Partner with Drug Product and Analytical colleagues to ensure DS physical attributes are understood, controlled, and appropriate for Drug Product manufacturing.
- Generate and document stage-appropriate data; contribute as an author and technical reviewer for DS sections of regulatory filings.
- Collaborate with internal and external stakeholders to deliver program objectives.
Skills and experience you’ll bring (required):
- Ph.D. in Chemistry or Chemical Engineering with 7+ years, or B.S./M.S. with 12+ years in Drug Substance Development.
- Experience bringing small molecule assets from late discovery through mid-phase clinical trials.
- Experience as DS lead on integrated CMC teams.
- Experience directing CRO/CDMO partners.
- Ability to write/review DS technical documents.
- Deep understanding of small-molecule drug development and how CMC integrates with Quality, Non-clinical Safety, Clinical, Regulatory, and IP.
- Familiarity with phase-based GMPs, manufacturing compliance requirements, and regulatory guidelines/expectations.
- Hands-on, urgent, fast-paced/agile work style.
- Ability to make sound, risk-based scientific and business decisions in ambiguous environments.
- Ability to conduct, manage, and communicate risk assessments.
Preferable experience:
- Develop data-driven crystallization processes using fundamental principles.
- Use statistical/modelling software for DS development and manufacturing decision-making.
- Design and execute process characterization using Quality by Design.
- Comfort with hands-on problem solving to unblock programs while maintaining strategic/technical leadership.
Compensation:
- Base salary range: $160,000–$240,000; eligibility for annual bonus, equity participation, and comprehensive benefits.
- Serve as the accountable Drug Substance lead for one or more development programs; own Drug Substance (DS) strategy, execution, and delivery from late discovery through clinical development.
- Use scientific, data-driven, and risk-based approaches to clinical and commercial route/process innovation and development, guided by safety and green chemistry principles.
- Provide technical leadership and oversight for outsourced DS development at CROs and CDMOs, ensuring quality, timelines, and scientific rigor.
- Lead DS technology for internal/external knowledge transfers (author transfer strategies, define success criteria, support manufacturing execution).
- Partner with Drug Product and Analytical colleagues to ensure DS physical attributes are understood, controlled, and appropriate for Drug Product manufacturing.
- Generate and document stage-appropriate data; contribute as an author and technical reviewer for DS sections of regulatory filings.
- Collaborate with internal and external stakeholders to deliver program objectives.
Skills and experience you’ll bring (required):
- Ph.D. in Chemistry or Chemical Engineering with 7+ years, or B.S./M.S. with 12+ years in Drug Substance Development.
- Experience bringing small molecule assets from late discovery through mid-phase clinical trials.
- Experience as DS lead on integrated CMC teams.
- Experience directing CRO/CDMO partners.
- Ability to write/review DS technical documents.
- Deep understanding of small-molecule drug development and how CMC integrates with Quality, Non-clinical Safety, Clinical, Regulatory, and IP.
- Familiarity with phase-based GMPs, manufacturing compliance requirements, and regulatory guidelines/expectations.
- Hands-on, urgent, fast-paced/agile work style.
- Ability to make sound, risk-based scientific and business decisions in ambiguous environments.
- Ability to conduct, manage, and communicate risk assessments.
Preferable experience:
- Develop data-driven crystallization processes using fundamental principles.
- Use statistical/modelling software for DS development and manufacturing decision-making.
- Design and execute process characterization using Quality by Design.
- Comfort with hands-on problem solving to unblock programs while maintaining strategic/technical leadership.
Compensation:
- Base salary range: $160,000–$240,000; eligibility for annual bonus, equity participation, and comprehensive benefits.