Manufacturing Associate, Liso-cel CAR- T - Summit West NJ

VetJobs; New Jersey; On-site; USD 79,901,000 - 96,432,000; Full time

Job summary

Summit West, NJ-based manufacturing role at Bristol Myers Squibb focuses on producing blood component lots through cell culture, harvest, and cryopreservation. The role supports CAPA closures, deviation investigations, and adherence to GDPs and GMP requirements within a cross-functional team.

The position requires understanding of biology/chemistry, cGMP/FDA practices, and strong documentation skills. On-site in Summit West with a shift pattern and training responsibilities outlined.

Qualifications

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills - general understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Background to include an understanding of biology, chemistry, medical or clinical practices.
• Pre-requisites: prior experience in Manufacturing and/or scientific/engineering education.
• Associate / Medical Technical degree and 3 years of Manufacturing.
• Operations experience.
• High School diploma/GED and 2 years of Manufacturing or Operations experience.

Responsibilities

• Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
• Support deviation investigations and write ups as needed.
• Support on time closure of any assigned CAPAs within the designated shift.
• Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
• Weighs and measures in-process materials to ensure proper quantities are added/removed.
• Adheres to the production schedule ensuring on-time, internal production logistics.
• Records production data and information in a clear, concise, format according to proper GDPs.
• Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
• Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Motivated, team consciousness individuals are needed to fulfill job requirements.
• Become a SME and qualified trainer within a designated function of manufacturing.
• Supervision will be managed by the shift Supervisor or designated Team Lead.
• Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.

Skills

Cell culture

Cryopreservation

Purification

Aseptic processing

cGMP/FDA

Technical writing

MS Office

Biology knowledge

Manufacturing experience

Operations experience

Education

Bachelor’s degree

High School/GED

Associate / Medical Technical degree

Job description

Education

Bachelor’s degree

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Duties/Responsibilities

• Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
• Support deviation investigations and write ups as needed.
• Support on time closure of any assigned CAPAs within the designated shift.
• Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
• Weighs and measures in-process materials to ensure proper quantities are added/removed.
• Adheres to the production schedule ensuring on-time, internal production logistics.
• Records production data and information in a clear, concise, format according to proper GDPs.
• Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
• Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Motivated, team consciousness individuals are needed to fulfill job requirements.
• Become a SME and qualified trainer within a designated function of manufacturing.
• Supervision will be managed by the shift Supervisor or designated Team Lead.
• Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.

Reporting Relationship

This position reports to the Manufacturing Manager.

Shift

Quad 3, 5 am-5:30 pm. Wednesday through Saturday (with e/o Wednesday off)

Auto req ID

482556BR

Minimum Education Required

High School/GED

Additional Qualifications/Responsibilities

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
• Knowledge of cGMP/FDA regulated industry
• Basic mathematical skills - General understanding of cGMPs
• Technical writing capability
• Proficient in MS Office applications
• Background to include an understanding of biology, chemistry, medical or clinical practices
• Pre-requisites: Prior experience in Manufacturing and/or scientific/engineering education
• Associate / Medical Technical degree and 3 years of Manufacturing
• Operations experience
• High School diploma/GED and 2 years of Manufacturing or Operations experience.

Working Condition (US Only)

Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. Must be comfortable working with contained human blood components. Physical dexterity sufficient to use computers and documentation. Sufficient vision and hearing capability to work in job environment. Ability to lift 25 pounds. Must have the ability to work around laboratories and controlled, enclosed, restricted areas. Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet. Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas. Flexibility to don clean room garments and personal protective equipment (PPE). Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected. Routine exposure to human blood components. Exposure to strong magnets is likely. Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Summit West - NJ - US: $27.83 - $33.72per hour

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

City*

Summit West

State*

New Jersey

Job_Category

Sales

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Bristol Myers Sqibb BMS

Salary Range

>$100,000