Manufacturing Associate, CAR- T - Summit West, NJ

VetJobs; New Jersey; On-site; USD 100,000 - 120,000; Full time

Job summary

VetJobs is seeking a Manufacturing Associate for the Cell Therapy team in Summit West, NJ. The role supports production of blood component lots in a cGMP cleanroom under supervision, with a Wednesday–Saturday overnight shift schedule (5 p.m. – 5:30 a.m.).

Responsibilities include equipment setup, deviation investigations, maintaining aseptic technique, data records, and cross-functional collaboration to meet production schedules. Requires a Bachelor’s degree and 0–1 year of related experience.

Qualifications

• Knowledge 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.

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.

Skills

Cell culture

Aseptic processing

cGMP/FDA

MS Office

Biology background

Education

Bachelor's degree

Job description

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. If you have the required skill set, education requirements, and experience, unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Role Statement

Our Manufacturing Associate, Cell Therapy team manufactures human blood derived components per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

Shift Available

Quad 4: Wednesday- Saturday (with e/o Wednesday off), Onsite Overnight Shift, 5 p.m. - 5:30 a.m.

• Start and end times are subject to change based on business demands.

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.
• Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc

Auto req ID

483063BR

Minimum Education Required

Bachelors

Additional Qualifications/Responsibilities

Knowledge & Skills:

• 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

Basic Requirements

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

Working Conditions

• Intermittent walking, standing and sitting to perform job functions; however, ability to 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 in 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, perfume/cologne and 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.
• Restricted areas prohibit food, any outside materials such as cell phones, tablets, at a minimum.

Compensation Overview

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

City*

Summit West

State*

New Jersey

Job_Category

Engineering

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Bristol Myers Sqibb BMS

Salary Range

>$100,000