Technical Lead - Downstream Manufacturing

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

MAJOR DUTIES AND RESONSIBILITIES:

• Works on routine manufacturing 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 first time through adherence of GMP activities.

• Change control identifiers – works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation.

• Communicate and resolve operational variances.

• Serve as the “acting” Shift Supervisor/Manager in absence of Shift Supervisor/Manager – 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 routine investigations in Infinity as a low-level lead investigator – drives technical issues working with cross functional team members.

• Support complex investigations and CAPAs – author, review, approval, in case of excess investigation beyond planned capacity.

• Actively involved in safety related GEMBA, safety 4-box and safe IM investigation.

• Actively involved in coaching of team members to prevent human related error and quality events.

• Supports issue escalation with key stakeholders, troubleshooting systems and equipment issues, and working collectively to drive resolution.

• Support real time process reports review and resolve open issues.  Trend issues and strives to right first time.

• Execute and drive continuous improvements such as procedure updates in electronic document repository (DCA)

• Supports Tech transfer team through active participation in ensuring that new process can fit and executes in a sustainable manner.

• Assigned area owner – drive facility upkeep through escalation of service requests, area walkthroughs, safety escalations (SAFE IM) and generation of safety communications.

• 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 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.). Regularly provides training and operational guidance to staff.  

• Effectively uses process automation systems (i.e., Delta V and Syncade Interactions, Pi Vision) and some supporting business systems (i.e., SAP, Infinity, Maximo etc.).

• Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions and that training is completed on time.

• Support mentoring and coaching of operators on safety, executing task with a quality mindset, and prioritizing daily task to drive schedule adherence. 

• Assists with the coordination and implementation of special projects such as validation, complex investig