Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations

Bristol Myers Squibb • Summit, NJ

1d • Onsite

About The Position

Bristol Myers Squibb is reimagining the future of cell therapy, aiming to unlock its full promise to transform patients' lives. Working at BMS offers a challenging, meaningful, and life-changing experience with opportunities for growth and development. The company values balance and flexibility, providing competitive benefits and programs. The Manufacturing Associate, Cell Therapy team is responsible for manufacturing human blood-derived components in a controlled, cGMP cleanroom environment, adhering to Batch Records and Standard Operating Procedures under the supervision of Manufacturing Management. Associates must comply with regulatory requirements, work within a team on an assigned production shift, and communicate production deviations while assisting with quality investigations as needed.

Requirements

• 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
• High School Diploma required
• 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience

Nice To Haves

• Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred
• Bachelor's or associate degree preferred

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

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees