Bioprocess Associate

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.

BMS is growing! We are proactively recruiting for some expected needs. Although these roles are not current open, we do expect them to officially be open for hire in the very near term. Please review the job descriptions below and apply now so that we can contact you as soon they open.

PRINCIPAL OBJECTIVE OF THE POSITION: The Bioprocess Associate/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).

Bioprocess Associate

Senior Bioprocess Associate

Bioprocess Specialist

Level – B21

Level – B22

Level – B23

MAJOR DUTIES AND RESPONSI-BILITIES

Works on routine manufacturing assignments per written procedures, 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 work instructions and maintains clean room environment to comply with regulatory requirements. Trains for proficiency in the operation of primary production equipment within the assigned functional area (i.e. bioreactors, chromatography skids, media or buffer preparation equipment etc.). Trains for proficiency in process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).

Assist with the revision and or creation of process documents, such as SOPs and work instructions. Assists in maintaining material and components inventory level. Supports safe work environment.

Works on routine manufacturing assignments per written procedures that are moderately complex with minimal instructions, 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 work instructions and maintains clean room environment to comply with regulatory requirements. Operates primary production equipment within the assigned functional area (i.e. bioreactors, chromatography skids, media or buffer preparation equipment etc.) as instructed.

Effectively uses in process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.) to maintain production records. Revises and creates process documents with little to no instruction, assists with process related investigations. Leads in maintaining material and components inventory level. Assists with reviewing batch and exception reports associated with each manufacturing lot, in conjunction with supervisor and Quality representative. Provide assistance for areas specific initiatives associated with work safety

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.

KNOWLEDGE AND SKILL

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. Prior evidence of successful participation on work/study teams where combined contribution, collaboration, and results were expectedDemonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.Work/study experience where attention to detail and personal accountability were critical to successDemonstrates 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 2+ years of process operations experience in a biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.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 expectedDemonstrated 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 successDemonstrates 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 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 expectedDemonstrated 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 successDemonstrates good interpersonal skills, is attentive and approachable. Maintains a professional and productive relationship with area management and co-workers.

CONTACTS

Bioprocess Associates 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 Associates/Specialists 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.

Bioprocess Senior Associates 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 Associates/Specialists 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.

Bioprocess Specialists 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 Associates/Specialists 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.

WORKING CONDITIONS

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.

DECISION MAKING

Take action, final decision, recommend /

Works on assignments that are routine in nature where judgment is required in resolving problems and making routine recommendations.

Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.

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.

SUPERVISION RECEIVED

Incumbents normally receive general instructions on routine work and detailed instructions on new assignments.

Incumbents normally receive no instructions on routine work and general instructions on new assignments.

Incumbents act with very limited supervision for routine activities to determine methods and procedures on new assignments

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.