Director, CMC Drug Substance
A small, multinational biotechnology company is currently seeking a driven, motivated, and enthusiastic Director, CMC Drug Substance. This position is remote. You will play a key role in overseeing external manufacturing processes with external vendors, ensuring the successful development and production of drug substance for our late-stage programs.
The Director will be responsible for:
- Provide leadership and guidance for external manufacturing partners to ensure the successful execution of late-stage development programs (ex. FMEA, process characterization, and validation)
- Collaborate with vendors to ensure compliance with quality standards, timelines, and budgetary constraints.
- Lead cross-functional teams and collaborate with internal stakeholders to drive drug substance development projects to successful NDA filing.
- Mentor and supervise a small team of junior staff, troubleshoot technical issues, and maintain comprehensive records for regulatory submissions.
The Director should have the following qualifications:
- PhD in Chemical Engineering, Chemistry, or a related scientific field with 8+ years of related CMC Drug Substance experience/Master's with 10+ years/Bachelor's with 13+ years
- Proven track record of successfully leading drug substance development programs through late-stage phases and NDA filing.
- Extensive experience with managing external partners/vendors along with the respective contracts, timelines, and budgets.
- Demonstrated ability to work effectively in a remote environment, maintaining high levels of productivity and accountability.