Director, Chemical Development

Responsibilities:
- Lead technical development strategy for small-molecule drug substances from IND-enabling through late-stage development and commercial readiness.
- Provide technical leadership for synthetic route design, process optimization, control strategy development, and scale-up/tech transfer to pilot/commercial (incl. GMP) at CDMO partners.
- Evaluate and select CDMO partners (process R&D, GMP capability, site visits) and support RFP/contracting.
- Oversee cGMP document review/approval (batch records, change controls, deviations, specifications, validation plans/protocols/reports).
- Define phase-appropriate drug substance control strategies (CQAs; specs for starting materials/intermediates).
- Drive safe, robust, scalable, cost-effective process development; conduct process characterization and fate/purge studies.
- Apply QbD and risk assessment across development, validation planning, and lifecycle management.
- Serve as drug substance lead on cross-functional CMC teams; support IND/IMPD and NDA/MAA CMC contributions and Health Authority responses.
- Support validation and commercial readiness (PPQ, continued process verification, lifecycle improvement) and ensure timely drug substance delivery.
- Partner on patent strategy and protect innovations; represent Chemical Development in governance and leadership discussions.

Qualifications:
- Ph.D. in chemistry with 12+ years small-molecule drug substance experience; or M.S. with 15+ years.
- Strong synthetic organic chemistry; process development, scale-up, and GMP manufacturing support.
- Solid-state properties expertise.
- Hands-on CDMO leadership experience; cGMP/quality systems knowledge.
- Knowledge of analytical methods and ICH; experience authoring CMC regulatory filings.
- Demonstrated cross-functional leadership and communication; problem-solving and attention to detail.
- Preferred: mentoring/matrix team experience.
- Ability to travel domestically/internationally.