Senior Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations • Value Stream CAR-T Manufacturing
PharmaBiotechRegulatory AffairsQuality Assuranceheorgmpemafdacroinformaws
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. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Manufacturing Associate manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. Shift Available: Quad 3 Wednesday - Saturday (with every other Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m. Responsibilities: Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms) compliantly Executes transactions and process in all electronic systems and adheres to business continuity procedures Role models and leaders for the culture of compliance, safety, and team dynamics Controlled document & Deviation authoring, change impact assessment and action owner Demonstrate a strong practical and theoretical knowledge in their work Can represent department in cross-functional department collaborations May be assigned Team Lead duties as needed / delegated Complete documentation required by Source Governing Documents contemporaneously Solve complex technical problems; takes new perspectives using existing solutions Perform all tasks in a manner consistent with the safety policies, Source Governing Documents, Quality Systems, and GMP requirements including ALCOA+ Complete training assignments prior to assigned due date to ensure the necessary technical skills and knowledge Trains for proficiency in process systems and some supporting business systems, and maintains trainer qualifications Train others on Source Governing Documents to successfully complete manufacturing operations Identify and propose innovative solutions • Continues to refine and improve manufacturing process technique and improve individual operational times. Work within a controlled cleanroom environment and perform aseptic processing (as assigned; 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 Cross-trained into multiple manufacturing processes (as assigned) Verifies training completion prior to performing any GxP tasks Knowledge & Skills: Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and 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, Cell Expansion processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment. Experience as a trainer Minimum Requirements: A minimum high school diploma and/or equivalent combination of education and experience is required. Associate or bachelor's degree in related field is preferred. 3+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience. Working Conditions: Must be able to stand/walk for extended periods of time Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials Work in areas that may have strong magnets Must be able to work in a BSL2 / ML1 work environment handling human blood components Work in areas with exposure to vapor phase liquid nitrogen Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays) We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. Compensation Overview: Summit West - NJ - US: $30.61 - $37.09per hour
 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance. Benefits: Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non
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