Manufacturing Supervisor

Global Life Science Hub is partnered with a science-led biologics biotech that’s launching a brand-new, state-of-the-art manufacturing facility in New Jersey looking to hire a new Manufacturing Supervisor to help build the new commercial Drug Substance team across both Upstream and Downstream operations.

With 4 cutting-edge manufacturing suites, the site is set to become the engine room for all new production and is being built to scale up to 20,000L capacity within the next 24-36 months.

• Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Provides technical direction in the execution and development of the purification process.
• Uses programs to collect and evaluate operating data to conduct on line adjustments to products, instruments or equipment.
• Prepare/ review all quality management related documents (Deviation / Change control / investigation reports etc.)
• Ensure that engineering and clinical batches are executed in a timely manner.
• Establishes operating equipment specifications and improves manufacturing techniques.
• Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
• Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.
• Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

• Requires a Bachelor or Master’ degree in chemical, biological or biochemical sciences and a minimum of 7 - 10 years of related experience in the biopharmaceutical industry.
• Previous experience working in GMP and aseptic manufacturing environment.
• Experience working with AKTA Process skids or similar and familiarity of single use manufacturing consumables such as bags, tube sets, columns and process manifolds.
• Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation.