Director, Bioprocess
Company Summary:
A small, clinical-stage biopharmaceutical research company is currently seeking a driven, motivated, and enthusiastic Director, Bioprocess. This position is located the Greater Boston area. You will play a key role in providing technical expertise for leading and developing early-stage clinical programs.
The Director, Bioprocess will be responsible for:
- Lead the scientific and technical direction in early-stage asset development, focusing on scalable processes using advanced methodologies and tools such as QbD and PAT.
- Develop, characterize, and scale-up drug substance processes to advance programs.
- Broaden expertise in microbial fermentation, scale-up, and purification to enhance the team's capabilities.
- Foster cross-functional collaboration within drug substance teams to deliver manufacturing processes, actively contributing to project milestones and objectives.
- Oversee the transfer of processes to GMP manufacturing.
- Produce technical publications, reports, and regulatory filings, presenting research in peer-reviewed journals and scientific conferences.
- Provide technical and scientific guidance to the team and ensure high-quality work is delivered on time and within budget.
- Manage and mentor a team of scientists and engineers.
The Director, Bioprocess 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.
- Microbial fermentation expression systems (yeast) - REQUIRED
- Demonstrated technical expertise in development and manufacturing of clinical phase programs (phase 1-3).
- 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.
Benefits:
- Opportunity to work on a hybrid schedule
- 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