Purpose & Scope:
In strict compliance with CGMP regulations, the Manufacturing Associate in the Cell Culture group, executes all routine operations of a biological product. The position performs duties under supervision and according to standard operating procedures.
Essential Job Responsibilities:
• With senior manufacturing personnel, executes all routine operations in the manufacturing of the Company’s RPE product.
• Operate and ensures proper maintenance of BSC’s, microscopes, incubators, centrifuges, pH meters, and other manufacturing equipment
• Able to perform aseptic technique in a biological safety cabinet, media changes, cell passaging and in-process testing.
• Completes required documentation following proper GMP recording of entries and comments in batch records, forms and protocols
• Initiate Document Change Requests; author, revise and review manufacturing documentation
• Clean and maintain equipment for use in CGMP operations including the handling of CO2 and Liquid Nitrogen tanks and systems
• Works within the team and department in order to follow best practices and meet department goals
• Reports any issues related to manufacturing performance, process and safety to management in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.
Required
• A Bachelor’s Degree with 2+ years’ experience is preferred, however an Associate’s Degree with focus on Biologics and 2-5+ years of relevant industry experience in biotechnological and/or pharmaceutical manufacturing will be considered.
• Production/Processing – Knowledge of raw materials, production processes, quality control, and other techniques for maximizing the effective manufacture of pharmaceutical products. Includes advanced knowledge of aseptic technique and basic lab instruments, (Centrifuge, Pumps, Scales, etc.)
• Biology – Knowledge of organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment
• Safety/Security – Knowledge of relevant equipment, policies and procedures to promote effective and safe operations for the protection of people, data and company property
Preferred
• Experience with embryonic or induced pluripotent stem (iPSC) cells
Annual CTC : -
Experience :
Industry : Social Services
Role :
State : California
County : Glenn
Education :
Employment Type : Contract