The Cell Culture Senior Operations Specialist works as part of a team to execute batch activities in a state of the art gene therapy manufacturing facility in Sanford, NC. The incumbent will have hands on experience and technical expertise in bioreactor operations with preference for experience in single-use technology. The incumbent will be responsible for performing GMP activities in any of the cell culture suites, but is expected to have the flexibility to perform operations across all areas (purification, solution prep, formulation/fill, pack/label) and all products. In addition to operating equipment the senior operations specialist will be responsible for:
Completing GMP documentation
Performing operator care activities
Identifying ways to improve work and implementing solutions
Leading and participating in investigations that address increasingly more complex issues
Troubleshooting equipment and automation related issues on the floor
Additional expertise should include one or more of the following others areas:
Downstream Purification Unit Operations
Formulation / Filling
Labeling / Packaging
Manufacturing and Quality Systems
The Senior Operations Specialist will be assigned as a team member on cross functional teams and be given project assignment to develop problem solving, technical expertise, and leadership capability while balancing primary responsibility of executing batch activities.
The incumbent must also comply with applicable safety, occupational health, loss prevention and environmental requirements.
Execute clinical production on-time and without injury or defect. Develop Operations Specialists knowledge and skillset in areas of personal expertise. Maintain inspection readiness of area. Own area change controls and commitments. Proactively implement improvements to business and manufacturing processes that improve flexibility, eliminate waste, and reduce variability. Ensure that all documentation aheres to documentation model standard.Maintain the accuracy of all documentation needed for operations including SOPs, batch records and compounding records. Implement 5S, standard work, visual management, special cause and common cause problem solving in area. Role model OWNIT! behaviors. Partner with EHS to build processes, tools, and mindsets that ensure a zero injury workplace. Author and approve quality and safety investigations and implementation of CAPA. Execute a robust operator care program.
A minimum of 5 years experience in biotech operations with a BS degree. Preferred disciplines include: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Microbiology or equivalent science related or engineering degree.
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