About this role
Position Summary:
The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at company CDMOs. This role is a critical contributor within Technical Operations (CMC) and broadly supports the product development, clinical manufacturing, commercial launch planning, logistics, and lifecycle management of small molecule drug products.
This individual will partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and successful achievement of program milestones. The successful candidate will bring substantial experience in small molecule API development and manufacturing, appropriate for advancing a late-stage development asset to commercial readiness.
Responsibilities
- Provide technical oversight of API production, scale up, process characterization, and process performance qualification (PPQ) for a small molecule, solid oral drug product manufactured at company CDMOs.
- Review and approve manufacturing-related documentation, including change n