Overview

Scientist contributing to the development of early and late stage clinical manufacturing processes and commercial manufacturing processes for Cell and Gene Therapies. This position will work with a team of scientists and technical specialists responsible for process development, technology transfer and GMP manufacturing to ensure the application of well-designed unit operations for inclusion in routine manufacturing operations supplying clinical and commercial materials. Responsible for supporting development project leads in the development, scale-up/out, and verification of clinical and commercial manufacturing processes. Contributes to operations of development team, and may support tech transfer activities as necessary. Demonstrates strong oral and written communication skills.

Responsibilities

  • Supports the successful process development and technology transfer of Cell and Gene Therapy products. Areas of focus include culture of adherent and suspension primary cells, such as but not limited to lymphocytes, stem cells, dendritic cells and other cell types, potentially transduced with nucleic acids or viral vectors; help with cell therapy process scale-up and optimization, technology development and process automation.
  • Contributes to activities required for successful operation of assigned project area including:
    • Writes detailed experimental protocols, reviews and reports data appropriately, contributes to technical reports.
    • Executes and documents experimental studies, authors local Standard Operating Procedures (SOPs) and purchasing plans.
    • Contributes to coordination of activities in the laboratory, maintains laboratories and equipment, reviews and signs logbooks.
  • Monitors and communicates inventory needs to the departments Materials Management group.
  • Communicates status of operations, safety and maintenance problems, in a timely manner to Area Management.
  • Contributes to training of new employees on areas of technical expertise and compliance issues relevant to the lab setting.
  • Understands and applies principles of biosafety to maintain a safe workplace for self and others.
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and Company Policies and Standard Operating Procedures.
  • Effectively communicates with clients and vendors.
  • Ability to work in a team environment and independently as required
  • Maybe required to work Holidays and weekends
  • Other duties as assigned

Qualifications

Experience / Education

  • Bachelors, or Master’s degree in Biology, Biochemistry, Immunology, Bioengineering or related field.
  • 2-4 years of relevant experience with a Bachelors’ degree
  • 0-2 years of relevant experience with a Masters’ degree

Knowledge / Skills / Abilities:

  • Experience in tissue culture of adherent and/or suspension cells is required.
  • Experience in unit operations such as centrifugation and cell washing techniques is required.
  • Experience with cell transfection/transduction is preferred.
  • Experience with authoring technical transfer protocols for cell/gene therapy products.

– provided by Dice

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