Aseptic Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations
Pharma
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. Our Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times. Shift Available: Sunday - Wednesday (with e/o Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m. Wednesday-Saturday (with e/o Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m. Responsibilities: Learn and execute Cell Therapy Manufacturing operations compliantly Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms) Executes transactions and process in all electronic systems and adheres to business continuity processes Prioritizes safety of self and others Reports safety events within 24 hours Immediately escalates any/all issues that may impact compliance or safety of self and/or others. Complete documentation required by Source Governing Documents contemporaneously Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+ Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge. Train for proficiency in process systems and some supporting business systems Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts Work within a control cleanroom environment and execute aseptic processing procedures (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 Continues to refine and improve manufacturing process technique to improve individual operational times. Verifies training completion prior to performing any GxP tasks Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements Knowledge & Skills: Proven experience working on teams where collaboration and results were expected Proficiency in common computer tools such as word processing, spreadsheet and web-based applications Meticulous attention to detail and personal accountability is critical to success Possess excellent interpersonal skills, is attentive and approachable Maintain a professional and productive relationship with area management and co-workers Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred Minimum Requirements: A minimum high school diploma. Associate or bachelor's degree in related field is preferred. 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education. 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 glas s es, ap r ons, face shields, p owe r ed 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 han dling human blood components. Work in areas with exposure to vapor phase liquid nitrogen. Must be able to work assigned shift (Day, Evening, Nigh t, Weekends and/or Holidays). #BMSCART, #LI-Onsite 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: $27.83 - $33.72per 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-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company
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