Gene Therapy Scientist Scientist IIJob DescriptionThe Scientist II is responsible for supporting all aspects of Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing (CMF). Working in collaboration with the Manager of Plasmids Operations and staff, the Scientist II will provide hands-on assistance for all day-to-day Plasmid Core production operations, including execution of production processes, documentation, as well as facility and equipment maintenance. A Scientist II will support production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by following appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing biological products.
Responsibilities- Support Plasmids resources and supply chain by ordering and maintaining materials inventory to meet production goals.
- Support daily operational activities related to the GMP manufacturing of biological products by ensuring the availability of materials with the proper documentation surrounding GMP activities.
- Work closely with Plasmids management to ensure continuous improvement objectives are identified and met using metrics and other statistical means.
- Operate and perform the calibration, validation, and cleaning of all facility equipment and systems as specified in SOPs.
- Assist in process documentation review, revision, remediation, and process change controls.
Skills & Qualifications- Bachelor's or Master's degree in Life Science field.
- 3+ years of experience working in Aseptic Processing, Cell Culture, or GMP.
- Experience in Drug Compounding, Drug Manufacturing, or Food Manufacturing/FDA preferred.
- Prior cell-based experience (either mammalian cell or eukaryotic cell) preferred.
- Knowledge and understanding of aseptic technique, cell culture, and liquid separation techniques.
- Experience leading projects and developing others preferred.
- Must be comfortable occasionally lifting/pushing/pulling 30 lbs.
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