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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

QC Analytical Specialist - Cell Therapy

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeNew Jersey, USAIn-person

About the Job

Requirements

  • Ability to accurately and completely understand, follow, interpret, and apply global regulatory and current Good Manufacturing Practice (cGMP) requirements.
  • Knowledge of Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and laboratory data analysis systems is preferred.
  • Ability to write technical documents is preferred.
  • Bachelor's degree or equivalent; a science degree is preferred.
  • At least 2 years of relevant analytical testing or quality control experience, or an equivalent combination of education and experience; experience in a regulated environment is preferred.
  • Demonstrated experience with cell and molecular biology techniques, including cell-based assays, flow cytometry, quantitative polymerase chain reaction (qPCR), enzyme-linked immunosorbent assay (ELISA), and aseptic technique.
  • Ability to perform lifting tasks up to 20 pounds at floor and waist height and lift up to 10 pounds overhead, and to push or maneuver carts to transport materials.
  • Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
  • Ability to independently don, doff, and wear required personal protective equipment, including lab coat or frock, gloves, and safety glasses or face shield, for prolonged periods while performing laboratory work.
  • Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals; work may involve handling dry ice, liquid nitrogen, and cryogenically cooled materials.
  • Ability to use step stools while reaching and handling materials.
  • Ability to work in a Biosafety Level 2 (BSL-2) environment.
  • Ability to perform work safely in accordance with Environment, Health, Safety and Sustainability (EHSS) procedures, including identifying and controlling risks, proper use of personal protective equipment, safe handling of chemicals and biological agents, compliance with waste and emergency procedures, and participation in training and safety programs.

Responsibilities

  • Perform routine testing of in-process, final product, and stability samples.
  • Perform testing for method transfer, validation, and verification.
  • Perform data verification and data review, and review Good Manufacturing Practice documentation for general methods.
  • May perform document revisions and tasks related to projects, corrective and preventive action (CAPA), deviations, investigations, and continuous improvement efforts.
  • Train analysts on general job duties.
  • Perform other tasks as assigned.

Desired Qualifications

  • Knowledge of Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and laboratory data analysis systems.
  • Experience writing technical documents.
  • Experience in a regulated environment.

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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