Manufacturing Supervisor (Downstream) - 12 Hour Night Shift
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Key details
- Salary
- $90K–$110K/yr
- Location
- Piscataway, NJ, United States
- Work style
- Onsite
- Level
- Senior
- Job type
- Full-time
- Experience
- 7–10 yrs
- Function
- Skilled trades & Manufacturing
- Focus area
- other
- Posted
- 2w ago
Skills
About the role
The Downstream Manufacturing Supervisor 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. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents.
Work in a team environment to execute batches and can work independently with minimum supervision. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.
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.)