Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR-T Manufacturing at Bris

Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR‑T Manufacturing job at Bristol Myers Squibb. Summit, NJ.

• Sunday – Wednesday (with alternating Wednesday off)
• Onsite Day Shift, 5 a.m. – 5:30 p.m.

• Execute operations described in Standard Operating Procedures (SOPs) and batch records.
• Execute transactions and processes in all electronic systems.
• Demonstrate strong practical and theoretical knowledge in routine manufacturing operations.
• Complete documentation required by governing controlled documents and batch records, ensuring right‑first‑time production.
• Solve complex problems, applying new perspectives using existing solutions.
• Be approachable and foster relationships while working through challenges and opportunities.
• Perform tasks in a manner consistent with safety policies, SOPs, quality systems, and GMP requirements.
• Evaluate team processing performance and communicate delays to leadership, proactively addressing bottlenecks.
• Complete training assignments to acquire the necessary technical skills and knowledge.
• Proficiently use process systems and supporting business systems.
• Assist in setting up manufacturing areas and equipment/fixtures as needed.
• Collaborate with support groups on recommendations and technical problem‑solving.
• Ensure shift operations run effectively in a cross‑functional team environment.
• Collaborate closely with Shift Supervisors/Managers to ensure seamless hand‑down and communication of operational status.
• Initiate deviations and support investigations/CAPA development; qualify as a deviation investigator and complete investigations timely.
• Complete change actions for change controls or investigations.
• Initiate and facilitate triage calls, providing support to Management as needed.
• Identify and propose innovative solutions.
• Support writing manufacturing operating procedures that are technically sound, efficient, and cGMP compliant.
• Train and qualify others on SOPs and work instructions for manufacturing operations.
• Support production planning to execute daily unit operations schedule across multiple shifts.
• Drive right‑first‑time execution of manufacturing unit operations, providing direct training, guidance, and problem solving.
• Coordinate daily work distribution according to the production schedule.
• Maintain schedule adherence and cycle time, reporting variances and impact to cross‑functional groups.
• Provide shift handover documentation as needed.
• Ensure shift notes communication is complete and accurate.
• Provide daily update summary to the functional group for SQDCP as needed.
• Maintain manufacturing environmental conditions by performing area disinfection regimens per global Health Authority requirements.
• Cross‑train into multiple processes (as assigned) as operator/verifier.
• Lead cross‑functional projects, ensuring timelines and deliverables are met.
• Attend Leadership Development training as a career development opportunity for future leadership roles.
• Shadow managers on leadership tasks, preparing for potential future responsibilities.

• Peer‑level on‑floor leadership experience demonstrating proficiency and schedule adherence.
• Aptitude for engineering principles and manufacturing systems.
• Proficiency in common computer tools, including word processing, spreadsheets, and web‑based applications.
• Good interpersonal skills; attentive and approachable.
• Professional and productive relationships with area management and co‑workers.
• Prerequisite:
  Senior Associate in Manufacturing.

• Bachelor's degree and 4 years of experience in cell therapy biopharmaceutical operations.
• OR Associate/Medical Technical degree and 6+ years of manufacturing operations experience.
• OR High School diploma/GED and 8+ years of manufacturing or operations experience.
• 1 year of training experience within the pharmaceutical industry.
• 1 year of troubleshooting technical issues on the manufacturing floor.
• Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing.

• Experience in cell therapy manufacturing, including cell washing processes and automated equipment.
• Experience with cell separation…