What are the responsibilities and job description for the Manufacturing Supervisor, Drug Substance position at Global Life Science Hub?
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:
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
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.
- 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
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
