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 looking for a Manufacturing Associate to join their CAR-T 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 Sunday - Wednesday shift (with every other Wednesday off) on an onsite day shift, from 5 a.m. to 5:30 p.m. The company emphasizes challenging and meaningful work that transforms patients' lives and offers opportunities for career growth and development.

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
survivor support
flexible time off (unlimited, with manager approval)
11 paid national holidays
160 hours annual paid vacation for new hires with manager approval
3 optional holidays
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
annual Global Shutdown between Christmas and New Years Day