Downstream Manufacturing Lead

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics in the Oncology and Infectious Disease fields. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.

To support further expansion, we seek an on-site Downstream Manufacturing Lead in Chicago who will be responsible for leading and growing the team while executing purification on a wide range of mammalian based biologics. The ideal candidate should posses technical expertise with various chromatography methods.

Responsibilities:

• 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. 

Requirements:

• 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

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com