Gene Therapy Laboratory Technician

The Technician 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 GMP Operations and staff, the Technician will provide hands-on assistance for all day-to-day GMP & Viral Vector Core production operations, including execution of production processes, documentation, as well as facility and equipment maintenance. The Technician will support production efforts to deliver all products in a timely, compliant, and fiscally responsible manner by following appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing biological products.

Responsibilities

• Support GMP 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 assuring the availability of materials with the proper documentation surrounding GMP activities.
• Work closely with GMP 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.

Essential Skills

• Experience working in Aseptic Processing or GMP.
• Experience in Drug Compounding, Drug Manufacturing, or Food Manufacturing/FDA.
• 1-2 years of experience in the scientific industry preferred.
• Strong knowledge in GMP, tissue culture, biology, cell culture, microbiology, mammalian, eukaryotic, and cell biology.