At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Technical Lead B24Major Duties and Responsibilities
Knowledge / Skills
- Works on routine mfg. assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations - striving for right the first time through adherence of GMP activities.
- Change control identifiers - works in conjunction with bioprocess associates/specialists to identify key improvement initiatives and direct changes to project leads for initiation.
- Investigation identifiers - initiate investigation following alignment with QA floor personnel.
- Communicate and resolve operational variances.
- Serve as the "acting" Shift Supervisor/manager in their absence - coordinate, direct and oversee work execution and manage personnel related issues.
- Executes real time process monitoring - including equipment and key process parameters, review and work with Shift Supervisor/Manager to drive required decisions.
- Drive implementation of process enhancement and new technology in partnership with Project Lead and Manufacturing Technology team.
- Participate in performance review discussion.
- Leads complex investigations on flor - drives technical issues in working with cross functional team members.
- Support real time process reports, review and resolve open issues. Trend issues and strives for right the first time.
- Technical trainer for the shift - provides consistent training to the staff.
- Execute and drive continuous improvements.
- Support tech transfer team through active participation in ensuring that new processes can fit and executes in sustainable manner.
- Being resource to support routine investigations and CAPA's - author, review, approval, in case of excess investigation beyond planned capacity.
- Assigned area owner - drive facility upkeeps
- Adheres to Good Manufacturing Practices and standard operating procedures.
- Weighs and checks raw materials. Assembles, cleans and sterilizes process equipment, monitors processes.
- Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
- Operates and trains others on all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipment or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.)
- Effectively uses process automation systems (i.e. DeltaV 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 (SOP's) and electronic work instructions and that training is completed on time.
- Assists with the coordination and implementation of special projects such as validation or complex investigations.
- May provide scheduling and work assignment guidance to peers. Modifies group work plan, schedule or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary, regularly provides training and operational guidance to other staff. Advises Shift Supervisor/Manager on improvements which may optimize work processes and informs of work issues requiring management action.
- B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
- A minimum of 5+ years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
- Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP) and strong technical knowledge of either upstream and/or downstream unit operation is essential.
- Demonstrated experience solving complex technical issues in biologics manufacturing.
- 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 are management and co-workers.
- Must be able to work as a self-starter and handle multiple priorities in a dynamic cross-functional team based environment.
Manufacturing Technical 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 with regard to inline sampling and variance investigation. Lesser but also important are the interactions with Materials Management and Maintenance staff for supplies and repair of equipment. Technical Lead will have daily contact with his/her supervisory staff for work assignments, coaching and general management discussions. In conjunction with Shift Supervisor/manager, Technical Lead leads shift huddles with cross functional team members. Occasional contact with other line management staff relating to specific project responsibilities may be expected.Working Conditions
Work is performed in a state-of -the-art large scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE). These roles require some contact with hazardous materials such as caustic and steam.Decision Making
May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.Supervision Received
Incumbents act independently to determine methods and procedures on new assignments.Supervision Exercised
Performs surrogate supervisor duties in absence of a Shift Supervisor/manager. Modifies group work plan, schedule, or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary, regularly provides training and operational guidance to other staff. Advises Shift Supervisor/Manager and Project Leads on improvements which may optimize work processes and informs of work issues requiring management action.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.