What are the responsibilities and job description for the Downstream Manufacturing Manager position at Global Life Science Hub?
Global Life Science Hub is proud to partner with a specialised Biopharmaceutical company leading the charge of next-generation drug delivery technologies and oral//biosimilar drug development.
To support further expansion, we seek a Downstream Manufacturing manager 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.
Essential Duties & 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 manager 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.
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
- 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 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
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
