This is an attractive position for a driven and skilled Manufacturing Scientist to lead the 3rd shift upstream operations for commercial-scale GMP runs using 2000L single-use bioreactors. This is your chance to be on the frontlines of innovation - driving scale-up success, optimizing bioreactor performance, and shaping the foundation of a new site.
As a key contributor to this next-generation facility, you?ll play a central role in ensuring the success of our upstream GMP production at scale. You?ll lead batch execution during the overnight hours, collaborate across functions, and continuously push the envelope on performance, quality, and compliance.
Location: New Jersey. Relocation assistance available for all non-local residents
Responsibilities: ? Take ownership of 3rd shift upstream GMP operations ? lead bioreactor scale-up and production for clinical and commercial programs. ? Optimize performance of single-use bioreactors (up to 2000L) to meet yield, quality, and schedule expectations. ? Translate process requirements into action ? refine equipment specifications and elevate upstream manufacturing techniques. ? Collaborate closely with Process Engineers, QA, and Tech Ops to ensure seamless, compliant execution of batch campaigns. ? Interpret and communicate protocols clearly (written, verbal, or diagrammatic) to guide a high-performing operations team. ? Drive GMP compliance and safety culture; lead by example in documentation, deviation investigations, and EHS initiatives. ? Participate in root cause analysis and corrective/preventative action (CAPA) for upstream process deviations. ? Maintain readiness through SOP reviews, batch record assessments, and continuous improvement initiatives.
Experience/Qualifications: ? Bachelor?s or Master?s degree in chemical, biological, or biochemical sciences. ? 3+ years of hands-on experience in biopharmaceutical manufacturing, with a strong focus on upstream/GMP operations. ? Proven ability to independently plan, execute, and document GMP production batches at pilot or commercial scale. ? Prior experience with single-use systems - bags, tubing, manifolds, sensors, etc. ? Comfortable leading shift teams, troubleshooting in real-time, and collaborating in a dynamic, fast-paced environment. ? A deep understanding of GMP, aseptic processing, and bioreactor scale-up from lab to production.
