CAR-T Manufacturing Associate – Cleanroom & Impact

Bristol-Myers Squibb Company; Summit (NJ); On-site; USD 38,000 - 46,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Vacation time (160 hours)

Job summary

Bristol Myers Squibb in Summit, NJ is hiring a Manufacturing Associate for the CAR-T team to manufacture human blood-derived components in a cGMP cleanroom under supervision.

The role follows Source Governing Documents and performs processes in electronic systems, prioritizing safety and quality. The shift is Sunday–Wednesday, onsite, 5 a.m.–5:30 p.m. Training and documentation are key parts of the job.

Qualifications

• 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.

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

Skills

cGMP knowledge

Math skills

cGMP understanding

Technical writing

MS Office

Inventory control

Biology background

Education

High school diploma

Associate or bachelor’s degree preferred

Tools

Electronic systems

Job description

Bristol Myers Squibb in Summit, NJ is hiring a Manufacturing Associate for the CAR-T team to manufacture human blood-derived components in a cGMP cleanroom under supervision.

The role follows Source Governing Documents and performs processes in electronic systems, prioritizing safety and quality. The shift is Sunday–Wednesday, onsite, 5 a.m.–5:30 p.m. Training and documentation are key parts of the job.