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QC Scientist, Cell Therapy Development Operation - Pharma
Ref No.: 20-00392
Location: Summit, New Jersey
Job Description:
  • The QC Scientist is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products.
  • This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot.
  • Additionally, when needed, this position will be able to assist with training and assay development, validation & transfer.
  • Perform testing of in-process, final product, and stability samples.
    • Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
    • Capable of handling complex issues and solving problems with only general guidance.
    • Prepare and present continuous improvement projects to management.
    • Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
    • Complete all work in a timely manner and focus on Right First Time (RFT).
  • Perform peer review of testing data.
    • Review all data in accordance with applicable procedures and cGMP requirements.
    • Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
    • Complete all reviews in accordance with required release timelines.
    • Communicate effectively with peers, and demonstrate collaborative teamwork, with regards to review of results.
  • Train new analysts to general job duties.
    • Complete necessary training to become a qualified trainer.
    • Perform training effectively.
    • Document training per procedural and cGMP requirements. Support document revision, project, CAPA, and investigation/deviation tasks.
    • Complete assigned tasks within a CAPA, deviation, or project on time
    • Participate in complex projects and continuous improvement efforts.
    • Take a leadership role, as required, for projects.
    • Draft and review technical documents, such as SOPs and protocols/reports.
    • Communicate effectively with management regarding task completion, roadblocks, and needs.
    • Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles. Performs other tasks as assigned.
  • Advanced hands on experience with various analytical techniques including ELISA, qPCR, FACS and scientific knowledge in the characterization and transfer of pharmaceutical products.
  • Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
  • Advanced technical writing skills.
  • Advanced problem-solving ability/mentality, technically adept and logical.
  • Ability to represent the interests of the group on cross-functional teams.
  • Ability to set priorities of the group and manage timelines.
  • Ability to work with management locally and globally.
  • Advanced ability to communicate effectively with team members, department management and cross- functional peers.
  • Bachelor's degree required, preferably in Science.
  • Advanced Degree preferred.
  • 5-8 years of relevant work experience, preferably in a regulated environment.
  • An equivalent combination of education and experience may substitute.

Working Conditions:
  • The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
  • The incumbent must analyze numerical values on a daily basis.
  • The incumbent will be required to work in a laboratory setting for extensive periods of time ranging from 4 to 10 hours per day.
  • The incumbent must be flexible to work in a rotating weekend holiday/schedule.
  • The incumbent will be working with and around biohazardous materials, including chemical agents.