Manufacturing Associate, CAR-T

Bristol Myers Squibb • Summit, NJ

1d • Onsite

About The Position

Bristol Myers Squibb is reimagining the future of cell therapy and is seeking a Manufacturing Associate, CAR-T to join their team. This role involves manufacturing human blood-derived components in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. The associate will adhere to regulatory requirements, communicate production deviations, and assist with quality investigations. The position is for a Day shift, Sunday - Wednesday (with every other Wednesday off), onsite.

Requirements

• Knowledge of cGMP/FDA regulated industry
• Basic mathematical skills
• General understanding of cGMPs
• Technical writing capability
• Proficient in MS Office applications
• Inventory control and/or management
• Background to include an understanding of biology, chemistry, medical or clinical practices
• A minimum high school diploma and/or equivalent is required.
• 0–1 year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education

Nice To Haves

• An associate or bachelor's degree in a related field is preferred

Responsibilities

• Create inclusive culture that builds relationships with support groups
• 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

• Medical, pharmacy, dental, and vision care.
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 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.
• Flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)) for US Exempt Employees.
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
• 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