Position Summary
- Sr. Director of Process Development (PD) and Manufacturing Science & Technology (MS&T) to lead CMC Technical Development, overseeing platform process development to support early- and late-stage pipeline products, and providing leadership to a team of scientists.
Responsibilities
- Serve as Head of Process Development (Upstream, Downstream) and MS&T, representing the function on cross-functional/cross-divisional teams with Analytical, Manufacturing, Supply Chain, Quality, and Regulatory.
- Strategically execute PD/MS&T to support current manufacturing campaigns and establish/optimize new platforms.
- Lead scale-up/scale-down model establishment and qualification for process characterization and manufacturing investigations.
- Author and review regulatory and process development documentation.
- Provide hands-on leadership and guidance to scientific staff.
- Foster development, coaching, and mentoring of a growing team of scientists.
Qualifications
- PhD (chemical/bio/bioprocessing/bioengineering/biochemistry/biological sciences or related) with 10 years biotech/biopharmaceutical industrial experience; or MS with 12 years; or equivalent; or BS with 15 years leadership experience.
- Viral vector process development experience required; hands-on AAV processing preferred.
- Proven success developing/optimizing processes while leading end-to-end PD/MS&T.
- Experience with process tech transfer, viral clearance, comparability, control strategies, process characterization, and process validations/PPQ.
- Excellent communication/presentation skills.
- Statistical analysis tools experience (e.g., JMP, Minitab) required.
- Strong MS Office skills (Word, Excel, PowerPoint) to author technical reports and presentations.