What are the responsibilities and job description for the USP/DSP Manufacturing Scientist position at Pharma Universe?
To support the next growth phase, we are recruiting several Scientists at multiple experience levels to help meet the increasing demands of Upstream and Downstream Manufacturing teams. These teams are preparing to scale from pilot manufacturing to full-scale commercial production in the company’s brand-new NJ facility.
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
USP Manufacturing Scientists:
- Execute mammalian cell culture processes to produce recombinant proteins for Biologics, managing cell culture batches up to 2000l
- Operate bioreactors, establish operating equipment specifications, and enhance manufacturing techniques.
- Collaborate with manufacturing associates and engineers, interpreting and providing instructions effectively.
- Initiate batch records, protocols, and oversee investigations in a cGMP environment to ensure compliance.
- Review and document manufacturing and packaging batch records and related documents, maintaining adherence to safety standards and GMP guidelines.
DSP Manufacturing Scientists
- Perform purification processes for mammalian cell cultures, including handling purification volumes up to 2000l
- Operate AKTA purification skids and TFF operations, contributing to column packing, process troubleshooting, and data analysis.
- Direct technical aspects of purification, collaborating with external vendors on production equipment maintenance.
- Maintain compliance with BLA requirements for clinical and engineering batches, following GMP policies and safety protocols.
- Manage batch execution, ensuring efficient issue resolution, batch documentation, and process improvements.
Experience/Qualifications:
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 prior experience in scale-up manufacturing activities.
Downstream:
- At least 1-2 years of experience in Downstream Processing with demonstrated expertise in TFF (Tangential Flow Filtration) operations.
- Hands-on experience in running chromatography systems and column packing, with knowledge in Unicorn software.
- Familiarity with depth filtration processes and knowledge of cGMP
