Bristol Myers Squibb Bioprocess Lead - Upstream Clinical Manufacturing in Devens, Massachusetts
Title: Bioprocess Lead - Upstream Clinical Manufacturing
Job Number: 1703769
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.
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 upstream unit operations (i.e. Media formulation equipment, glass washers, bioreactors, harvest equipment, buffer equipment, membrane operations, 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 and 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.
Bioprocess Leads will work in teams and have continual interaction with members of his/her team as well as other bioprocess teams throughout the manufacturing process in order to exchange information regarding the batch(s) in process. In addition there will be frequent contact with members of the Quality department, Materials Management and Maintenance staff for supplies and repair of equipment. All Bioprocess Leads will have daily contact with her/ his supervisory staff for work assignments, coaching and general discussions. Occasional contact with other line management staff relating to specific project responsibilities may be expected. Work is performed in a biologics drug substance manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE). These roles require some contact with hazardous materials such as caustics and acids. May work on assignments that are extremely complex in nature where action and a high degree of initiative are required in resolving problems and developing recommendations. Incumbents act with very limited supervision for routine activities to determine methods and procedures on new assignments. May act on shift supervisor or managers behalf in the absence of shift supervision for moderate periods of time (4-12 weeks).
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 upstream 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.
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
Bristol-Myers Squibb is an equal opportunity employer - Minorities/Females/Protected Veterans/Disabled
Job: Gen/Multi Mfrg Ops