Manufacturing Associate

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.