Director or Senior Director, API Development

Responsibilities:
- Provide leadership and technical guidance for selection, transfer, and management of new CDMO manufacturing activities.
- Lead current drug substance manufacturing process and optimize for continuous improvement.
- Support ongoing CDMO manufacturing activities; troubleshoot issues and non-conformities.
- Identify and resolve gaps for regulatory compliance with drug substance manufacturing and development.
- Support formulation development via drug substance optimization, impurity identification, and pre-clinical study coverage.
- Author and review drug substance IND-enabling protocols, reports, and regulatory submissions.
- Support formulation development for new entity optimization and synthetic route creation/advancement.
- Produce intellectual patent assessments and complete development projects to advance IP generation.

Qualifications (required/preferred):
- PhD/Master’s/Bachelor’s in a physical science field (ideally chemistry, chemical engineering, or biomanufacturing).
- ≥8 years in small molecule medicinal chemistry, API development, and/or manufacturing.
- Experience with IND-enabling development and authoring; managed CDMOs for initial development, manufacturing, process validation, and transfer.
- Knowledge of analytical technologies: LC, GC, NMR, MS, XRPD (and related methods for elucidation/purity).
- Well-informed of FDA, EU, and ICH guidelines for drug substance manufacturing and quality.
- Strong written/verbal communication and interpersonal skills; attention to detail; strong technical/analytical skills (ChemDraw, MS Office).

Benefits (if applicable in posting):
- Annual performance incentive bonus, new hire equity package, medical/dental/vision, 401(k) match, PTO, and paid holidays.