Manufacturing Tech Lead - Night Shift

Bristol Myers Squibb; Harvard (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Bristol Myers Squibb in the United States is seeking a Technical Lead to serve as the shift's technical expert for commercial manufacturing of therapeutic proteins under cGMPs, with a 5PM–5AM rotating schedule (3-2-2).

You will oversee routine and complex manufacturing tasks, drive process improvements, lead investigations and CAPAs, and coach team members to ensure safety, quality, and schedule adherence.

Qualifications

• BS in science, engineering, biochemistry or related discipline.
• Minimum 5+ years of GMP-driven process operations in automated biotech manufacturing.
• Strong knowledge of GMP regulations and SOPs; experience in upstream and/or downstream unit operations.
• Proven ability to solve complex technical issues in biologics manufacturing.

Responsibilities

• Operate and oversee routine and complex manufacturing assignments.
• Coordinate change controls and drive process improvements.
• Act as acting Shift Supervisor/Manager in absence of the supervisor.
• Perform real-time process monitoring and data review.
• Lead investigations and CAPAs with cross-functional teams.

Skills

GMP knowledge

Process monitoring

Leadership

Problem solving

Coaching

Safety culture

Education

BS in science/engineering/biochemistry or related

Tools

DeltaV

Syncade

Pi Vision

SAP

Maximo

Infinity

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Summary

The Technical Lead is the shift's technical expert in the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs). Shift: 5PM - 5AM rotating 3-2-2

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 investigations, and protocol execution.

KNOWLEDGE AND SKILL

• B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
• A minimum of 5+ year's 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 and operational knowledge of either upstream and/or downstream unit operation is essential.
• Demonstrated experience in solving complex technical issues in biologics manufacturing.
• Prior evidence of successful participation on w