Downstream Manufacturing Scientist
1 month ago
Medix is hiring a Downstream Manufacturing Scientist to join a company that specializes in the development and distribution of biosimilar products. This is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. You'd work in a team environment to execute batches and can work independently with minimum supervision.
Essential Duties & Responsibilities
- Perform 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.
Position Requirements and Qualifications
- Requires a Bachelor or Master’ degree in chemical, biological or biochemical sciences and a minimum of 2+ 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.
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