Global Life Science Hub are seeking a Downstream Manufacturing Manager who will be responsible for executing purification on CHO cell culture processes and producing proteins for a wide range of mammalian based biosimilars. The appointed candidate will require technical expertise in Cell Biology and Bioreactor Operations.
Essential Duties & 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
- 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.
Experience/Qualifications:
- Requires a Bachelor or Master' degree in chemical, biological or biochemical sciences and a minimum of 8 - 12 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