Downstream Processing Supervisor Apply
Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics. 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 a Downstream Manufacturing Supervisor 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 –
