Bristol Myers Squibb Bioprocess Lead - Upstream in Devens, Massachusetts
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.
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 equipment, Buffer equipment, chromatography skids, membrane operations, column packing skids, etc.)
Effectively uses and possesses 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.
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 of 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.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled