Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts. The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site. Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Upstream Bioprocess Specialist - Biologics - assists in the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs).
This position requires working a shift schedule of 5AM-5PM which includes every other weekend and holidays as needed.
- Works on routine manufacturing assignments per written procedures that are complex, where ability to recognize deviation from accepted practice is required
- Adheres to Good Manufacturing Practices and standard operating procedures
- Weighs and checks raw materials
- Assembles, cleans and sterilizes process equipment, monitors processes. Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements
- Operates all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipment)
- Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.)
- Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions
- Assists with the coordination and implementation of special projects such as validation or complex investigations
- Revises and creates process documents with no instructions, supports routine process investigations
- Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative
- Champions area specific initiatives associated with work safety
- Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment.
- Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
- Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications
- Previous work experience where attention to detail and personal accountability were critical to success
- Demonstrates good interpersonal skills, is attentive and approachable
- Maintains a professional and productive relationship with area management and co-workers
- High school diploma is required. Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is desired but not required
- A minimum of 5 years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations
- Strong knowledge of Upstream operations is essential
- Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP)
Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/Disability
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