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Jobs · Analyst · New Jersey

Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations

Bristol Myers Squibb · Summit, NJ · Yesterday
On-siteAnalyst$27.83–$33.72/hrFull-time

About the role

Manufactures human blood derived components per Standard Operating Procedures (SOPs) 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

Q4: Wednesday - Saturday (with every other Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m.

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 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 conscious 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.

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

Minimum Requirements

  • High School Diploma required. Bachelor's or associate degree preferred
  • 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience

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

Pay

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

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

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