Sr. Bioprocess Associate, Downstream Clinical Manufacturing - 2p-10p
About the Job
At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.
Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.
We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.
Reporting to the Shift Supervisor, Devens Clinical Manufacturing, the Sr. Bioprocess Associate of Downstream 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.
· Operates primary production equipment to complete process steps including buffer preparation, column packing, chromatography and filtration in a clean room environment.
· Adheres to Good Manufacturing Practices and standard operating procedures. Must recognize deviations from accepted practice.
· Works on routine manufacturing assignments per written procedures that are moderately complex with minimal instructions.
· Revises and creates process documents, i.e. SOP’s and Batch Records, with little to no instruction and assists with process related investigations.
· Effectively uses in 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.
· A minimum of 2+ years of downstream process operations experience in a biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
· Practical knowledge of regulations such as GMP’s and company Standard Operating Procedures (SOP). Previous experience with single use technology a plus.
· Prior evidence of successful participation on work 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.
Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers