Director, Downstream Process Development
A small, clinical-stage biopharmaceutical research company is currently seeking a driven, motivated, and enthusiastic Director, Downstream Process Development. This position is located the Greater Boston area. You will play a key role in providing technical expertise for tech transfers of clinical stage CMC programs through CDMO management.
The Director, Downstream Process Development will be responsible for:
- Oversee the technical transfer of downstream processes to CDMOs and ensure successful execution of tech transfers
- Provide technical and scientific guidance to the team and ensure high-quality work is delivered on time and within budget
- Design and execute experiments to evaluate and optimize process parameters and identify process improvements
- Work cross-functionally with upstream process development, analytical development, quality control, quality assurance, and regulatory affairs teams
- Manage and mentor a team of scientists and engineers
The Director, Downstream Process Development should have the following qualifications:
- Master's degree in Chemical Engineering, Chemistry, Biochemistry, or Biology 10+ years of related industry experience or PhD degree with 8+ years of related experience
- Demonstrated technical expertise in development and manufacturing of clinical phase programs (late-phase experience preferred)
- Highly desirable to have direct experience with vaccines or recombinant biologic products.
- Developed leadership skills and effective communication of business objectives and technical information.
- Proven ability to manage and coordinate both internal and external deliverables.
- Competitive health, vision, and dental benefits with a 401(k) plan
- Company stocks and annual bonus
- Opportunity to work for a highly recognized and awarded company