Job Details

Manufacturing Associate, Cell Therapy

Manufacturing/Ops

icon-location-marker Summit West - NJ - US
Posted 23 days ago Full_time R1539704

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose and Scope of Position:
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. Day shift structures are Quad 1 5 am-5:30 pm, Sunday through Tuesday and every other Wednesday or Quad 3, 5 am-5:30 pm, Thursday through Saturday and every other Wednesday. Night shift structures are Quad 2 5 pm-5:30 am, Sunday through Tuesday and every other Wednesday or Quad 4, 5 pm-5:30 am, Thursday through Saturday and every other Wednesday. Start and end times are subject to change based on business demands.

Duties and Responsibilities:
  • Production of blood component lots through selection, activation, transduction, cell culture, harvest, and cryopreservation.
  • Aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum.
  • 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 GDocPs.
  • 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.
  • No direct reports will be assigned to this job role.
  • Performs other tasks as assigned.

Required Competencies:
Knowledge/ Skills, and Abilities:
  • Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
  • General understanding of cGMP/FDA regulated industry
  • Familiarity with Lean Manufacturing initiatives
  • 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

Education and Experience:
  • Bachelor’s degree
  • or Associate/ Medical Technical degree and 2 years of Manufacturing
  • or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience.

Working Conditions:
  • Intermittent walking, standing and sitting to perform job functions; however, ability stand for extended periods of time may be necessary.
  • Physical dexterity sufficient to use pipettes, laboratory equipment, computers and documentation.
  • Sufficient vision and hearing capability to work in job environment.
  • Ability to lift up to 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.
  • Jewelry, 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.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.