Manufacturing Associate, CAR-T

Manufacturing Associate, CAR‑T Shift Available

• Sunday - Wednesday (with e/o Wednesday off), Onsite Day shift, 5 a.m.
  
  - 5:30 pm.

• 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 processes 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 controlled 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 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. An associate or bachelor’s degree in a related field is preferred
• 0–1 year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education

• 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 but 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)

Summit West - NJ - US: $27.83 - $33.72 per hour. The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience.

Final, individual compensation will be decided based on demonstrated experience.

• 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…