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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Manufacturing Associate - CAR-T

Bioprocess & BiomanufacturingPosted on Nov 11
Full-timeNew Jersey, USA

About the Job

Requirements

  • A minimum high school diploma or equivalent is required.
  • A preferred associate or bachelor's degree in a related field.
  • Zero to one year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education.
  • Knowledge of the cGMP/FDA-regulated industry and a general understanding of cGMPs.
  • Basic mathematical skills and technical writing capability.
  • Proficiency in Microsoft Office applications.
  • Inventory control and/or management knowledge.
  • A background including an understanding of biology, chemistry, medical, or clinical practices.
  • Ability to stand and walk for extended periods.
  • Ability to work in a cleanroom environment and perform assigned aseptic processing in ISO 5 biosafety cabinets while wearing required gowning and personal protective equipment.
  • Ability to lift and/or carry up to 30 pounds several times a day while handling production equipment and/or materials.
  • Ability to push and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
  • Ability to work in areas with strong magnets and exposure to vapor-phase liquid nitrogen.
  • Ability to work in a BSL2/ML1 environment handling human blood components.
  • Ability to work the assigned shift, which may include day, evening, night, weekends, and/or holidays.

Responsibilities

  • Manufacture human blood-derived components according to batch records and standard operating procedures in a controlled cGMP cleanroom environment, adhering to regulatory requirements.
  • Communicate production deviations and assist with quality investigations as applicable.
  • Execute operations as outlined in source governing documents, including standard operating procedures, work instructions, batch records, and forms.
  • Execute transactions and processes in electronic systems and adhere to business continuity processes.
  • Prioritize personal and team safety, report safety events within 24 hours, and immediately escalate issues that may affect compliance or safety.
  • Complete documentation required by source governing documents contemporaneously.
  • Perform all tasks consistently with safety policies, standard operating procedures, quality systems, and good manufacturing practice requirements, including ALCOA+.
  • Complete training assignments before their due dates and train to proficiency in process systems and supporting business systems.
  • Execute the daily unit operations schedule, coordinating people, product, and material flow across multiple shifts.
  • Work in a controlled cleanroom environment and perform assigned aseptic processing procedures.
  • Maintain manufacturing environmental conditions, including non-viable particulate and viable microbial levels, through required area disinfection to meet global health authority requirements.
  • Refine and improve manufacturing process techniques to improve individual operational times.
  • Verify training completion before performing any GxP tasks.
  • Author manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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