- Expiry Date: 22 October 2021
Operates control systems and processes in Biotechnology Pilot Plants as assigned. Prepares process buffers and reagents. Cleans equipment and maintain area in clean and orderly fashion. Recognizes and reports safety, Bioprocess Associate of Upstream Clinical Manufacturing is responsible for advancing the mid to late stage clinical pipeline according to established work instructions and in accordance with current Good Manufacturing Practices (cGMPs). The Clinical Manufacturing Building (CMB) is a brand new, state of the art facility utilizing single-use technology.
Key responsibilities include:
Weighs and checks raw materials. Assembles, cleans and autoclaves process components. Assists in maintaining material and component inventory levels. Trains for proficiency in the operation of primary production equipment to complete process steps including media preparation, aseptic transfers, and cell culture and harvest operations in a clean room environment. Adheres to Good Manufacturing Practices and standard operating procedures. Recognize deviations from accepted practice and report to supervision. Works on routine manufacturing assignments per written procedures that are moderately complex with minimal instructions. Assists in revising and creating process documents, i.e. SOPs and Batch Records, and assists with process related investigations. Trains for proficiency with process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.) to maintain production records. Assists with reviewing batch and exception reports associated with each manufacturing lot, in conjunction with supervisor and Quality representative. Provide assistance for areas specific initiatives associated with work safety
Knowledge of science generally attained through studies resulting in a B.S., in engineering, biochemistry or science related discipline is desired but not required.
Prior experience where attention to detail and personal accountability were critical to success
Prior evidence of successful participation on work/study teams where combined contribution, collaboration, and results were expected. Maintains a professional and productive relationship with area management and co- workers.
Demonstrates good interpersonal skills, is attentive and approachable. Takes responsibility for personal safety and contributes to establishing a safe workplace environment.
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
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