Negotiable Salary
Pharma Universe
Edison, NJ, USA
This is an exciting opportunity for an experience Downstream Manufacturing Manager to be apart of an exciting mission by joining a rapidly growing startup in the enzyme biotechnology space. The appointed DSP Manager will lead the DSP operations. This role is critical for driving enzyme purification processes from pilot to production scale, ensuring consistent product quality, and supporting scale-up activities in a startup manufacturing environment. Key Responsibilities: Lead downstream processing activities including cell harvest, clarification, protein/enzyme purification (chromatography, filtration), concentration, and formulation. Develop, optimize, and scale downstream unit operations to support clinical and commercial manufacturing. Work cross-functionally with upstream, analytical, and quality teams to meet production and product specifications. Implement and enforce GMP-compliant operations and documentation. Support tech transfer, process validation, and continuous improvement initiatives. Manage and mentor junior engineering and operations staff. Qualifications: M.S. or Ph.D. in Biochemical Engineering, Biotechnology, or related field. 5+ years of experience in downstream processing, preferably with enzyme or biologic products. Hands-on experience with purification technologies such as TFF, UF/DF, AKTA systems, column chromatography, etc. Familiarity with bioreactor harvest protocols and scale-up operations. Strong understanding of regulatory and quality standards (GMP, FDA, etc.). Startup or small company experience a plus.