Manufacturing Associate

Marlborough, Massachusetts
Industry: Scientists / Research / Lab Technician
Job Number: JN -032021-61026

Title: Manufacturing Associate

Location: Marlborough, MA

Job Type: Long Term Contract

 

Responsibilities:

  • 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.

 

Required Skills:

  • 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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