The Downstream Manufacturing Scientist is a hands-on position responsible the purification of 50L to 1000L volumes of clinical and commercial batches in a cGMP environment. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.
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
Education:
- Requires a Bachelor degree in chemical, biological or biochemical sciences.
- 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.
