What are the responsibilities and job description for the Upstream or Downstream Manufacturing Scientist position at Pharma Universe?
To support our next growth phase, we are hiring seven Manufacturing Scientists at various experience levels to meet the increasing demands of our Upstream and Downstream Manufacturing teams. These teams are gearing up to scale from pilot manufacturing to full-scale commercial production at our new NJ facility.
Positions Available:
Upstream:
Positions Available:
- Manufacturing Scientist I: 1-2 years of USP/DSP Manufacturing experience
- Manufacturing Scientist II: 2-5 years of USP/DSP Manufacturing experience
- Manufacturing Scientist III: 6 years of USP/DSP Manufacturing experience
- Execute mammalian cell culture processes to produce recombinant proteins for biologics, managing cell culture batches up to 2000L
- Operate bioreactors, establish equipment specifications, and enhance manufacturing techniques
- Collaborate with manufacturing associates and engineers, providing clear instructions and guidance
- Initiate batch records, protocols, and oversee investigations in a cGMP environment to ensure compliance
- Review and document manufacturing and packaging batch records, ensuring adherence to safety standards and GMP guidelines
- Perform purification processes for mammalian cell cultures, handling purification volumes up to 2000L
- Operate AKTA purification skids and TFF operations, contributing to column packing, process troubleshooting, and data analysis
- Oversee technical aspects of purification, collaborating with external vendors on production equipment maintenance
- Ensure compliance with BLA requirements for clinical and engineering batches, adhering to GMP policies and safety protocols
- Manage batch execution, ensuring efficient issue resolution, batch documentation, and process improvements
Upstream:
- At least 1-2 years of experience in cell culture and bioreactor operations, including GMP and aseptic manufacturing experience
- Proficiency with single-use manufacturing consumables (e.g., bags, tube sets, columns) and experience in scale-up manufacturing activities
- At least 1-2 years of experience in downstream processing with expertise in TFF (Tangential Flow Filtration) operations
- Hands-on experience with chromatography systems and column packing, with knowledge of Unicorn software
- Familiarity with depth filtration processes and knowledge of cGMP
Upstream Manufacturing Scientist
Pharma Universe -
Piscataway, NJ
Downstream Manufacturing Scientist
Unicon pharma -
Piscataway, NJ
Downstream Manufacturing Scientist
Pharma Universe -
Piscataway, NJ
