Bioprocess Lead - Downstream

Bristol Myers Squibb Devens , MA 01434

Posted 3 weeks ago

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Bioprocess Lead leads and drives the execution of manufacturing processes according to established work instructions and production records for the manufacture of therapeutic proteins in accordance with Current Good Manufacturing Practices (cGMP's). The Bioprocess Lead is responsible for daily oversight of group whose primary focus is on execution of manufacturing processes, technical assessment of processes, maintaining a culture of compliance, innovation, and within their functional group. The Bioprocess lead is required to guide the shift personnel in their group with knowledge and technical knowledge to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements.

Responsibilities:

Adheres to Good Manufacturing Practices and standard operating procedures.

Oversees the use of production equipment and systems to support biologics production which includes either upstream or downstream unit operations (i.e. Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipments Buffer equipment, chromatography skids, membrane operations, column packing skids, etc.) Effectively uses and possess mastery for 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 work instructions and that training is completed on time. Under direction of area management, leads 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. Reviews batch documentation for completeness and accuracy. Resolves document execution issues. Champions areas specific initiatives associated with work safety and operational improvements. Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment. Advises Shift supervisor or manager on improvements which may optimize work processes. Works on routine manufacturing assignments as well as assignments that are complex in nature where action and a high degree of initiative are required in resolving problems and making recommendations as required.

Qualifications:

  • 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 biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.

  • Strong knowledge of either upstream or downstream unit operation is essential.

  • Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP).

  • 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.

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.


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Bioprocess Lead - Downstream

Bristol Myers Squibb