CAR-T Cell Therapy Manufacturing Associate

1010 Celgene - Summit (Corp); New Jersey; On-site; USD 38,000 - 46,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Insurance benefits

Job summary

Bristol Myers Squibb is seeking a Manufacturing Associate for the CAR-T team in Summit West, NJ. You will manufacture human blood-derived components per batch records and SOPs in a cGMP cleanroom under supervision. Shift is Sunday-Wednesday, 5 a.m.

to 5:30 p.m., onsite. Responsibilities include maintaining safety, executing operations per governing documents, documenting activities, and training to operate process systems and related business tools.

Qualifications

• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.

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/FDA regulated industry

数学基础

Basic mathematical skills

General understanding of cGMPs

Technical writing

MS Office

Inventory control

Biology/Chemistry background

Education

Associate or Bachelor's degree in a related field

Job description

Bristol Myers Squibb is seeking a Manufacturing Associate for the CAR-T team in Summit West, NJ. You will manufacture human blood-derived components per batch records and SOPs in a cGMP cleanroom under supervision. Shift is Sunday-Wednesday, 5 a.m.

to 5:30 p.m., onsite. Responsibilities include maintaining safety, executing operations per governing documents, documenting activities, and training to operate process systems and related business tools.