Bristol Myers Squibb Bioprocess Specialist - Downstream in Devens, Massachusetts
The Bioprocess Specialist assists in 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 (cGMPs).
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.
Adheres to Good Manufacturing Practices and standard operating procedures.
Weighs and checks raw materials. Assembles, cleans and sterilizes process equipment, monitors processes.
Completes work instructions and maintains clean room environment to comply with regulatory requirements.
Operates all 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 supervisor or Technical SME, 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 independently.
Reviews batch and for each manufacturing lot in conjunction with Quality representative. Resolves issues. Develops CAPA as necessary to expedite lot release.
Champions areas 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. Advises Shift supervisor on improvements which may optimize work processes.
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 4+ years process operations experience in a biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
Strong knowledge of upstream or downstream unit operations 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.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.