Posted on: March 10, 2021
Industry: Scientists / Research / Lab Technician
Job Number: JN -032021-61026
Title: Manufacturing Associate
Location: Marlborough, MA
Job Type: Long Term Contract
- With appropriate training, independently executes all routine operations in the manufacturing of the Company’s RPE product.
- Operate and ensure proper maintenance of BSC’s, microscopes, incubators, centrifuges, pH meters, and other manufacturing equipment.
- Able to perform aseptic technique in a biological safety cabinet including but not limited to media preparation, media changes, cell passaging and in-process testing.
- Independently completes required documentation and guide other operators on proper cGMP recording of entries and comments in batch records, forms and protocols.
- Initiate Document Change Requests; author, revise and review manufacturing documentation.
- Assist in the completion of deviations and CAPAs of moderate complexity and scope.
- 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.
- Assists in the training of new or junior staff on unit operations, cell culture and cell separation.
- BA degree with focus on Biologics and 2-4+ years of experience or equivalent experience.
- Production/Processing - Knowledge of raw materials, production processes, quality control, and other techniques and concepts for maximizing the effective manufacture of pharmaceutical products.
- Includes advanced knowledge of aseptic technique and basic lab instruments, (Microscope, 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.
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