Execute operations described in Standard Operating Procedures (SOPs) and batch records Lead the matrix FLS (frontline support team) a cross departmental team (QA, QC, F&E, IT, MFG, MSAT, SC&L) Responsible for schedule adherence, cycle time and issue resolution. Report variances and communicate/mitigate impact to cross functional groups Own deviations and leads investigations / CAPA development Qualified as a deviation Lead investigator, responsible for medium and high complex investigations across all manufacturing unit operations. Lead investigator (medium and complex investigations >technical, compliance and EHSS investigations) Qualified trainer for all GMP operations, closed and open operations, including all grade B aseptic handling. Owner of GMP documentation, controlled documents and batch records. Responsible for manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements Solve complex problems; takes new perspectives using existing solutions. Operational trouble shooting Production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements Demonstrate a strong practical and theoretical knowledge in their work and guide team members in issue resolution Execute operations described in Standard Operating Procedures (SOPs) and batch records Executes transactions and process in all electronic systems Demonstrate a strong practical and theoretical knowledge in their work Perform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements Complete training assignments to ensure the necessary technical skills and knowledge Proficient in process systems and supporting business systems Setting up manufacturing areas and equipment/fixtures, as needed Collaborate with support groups on recommendations and solving technical problems. Ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule Collaborate closely with Managers to ensure seamless pass down and communication of operational status Completes change actions for change controls or investigations Initiates and facilitates triage calls Identify and propose innovative solutions Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving Aid in daily work coordination and distribution as demanded through the production schedule Ensure shift notes and hand over communication is complete and accurate, as needed Leads Tier 1 and Tier 2 meetings Delegate for manager MBO 3 of 4 in science related field and/or equivalent 4+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired. Demonstrated aptitude for engineering principles and manufacturing systems. Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications. Demonstrated good interpersonal skills, is attentive and approachable. Maintain a professional and productive relationship with area management and co-workers. Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.