WuXi AppTec

  • Senior Scientist-Cell Therapy/CAR-T

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4331
  • Overview

    Independent scientist contributing to the development of early and late stage clinical manufacturing processes and commercial Cell Therapy manufacturing processes, with a focus on Cell and Gene Therapy programs and vector production.  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 development, scale-up/out, and verification of clinical and commercial manufacturing processes.  Contributes as to tech transfer and manufacturing activities as necessary.  Demonstrates strong oral and written communication skills, and supports client facing activities for the Cell Therapy Process Development team.  Contributes to the achievement of company and departmental goals and objectives. 

    Responsibilities

    • Responsible for successful process development and technology transfer of Cell Therapy products, with a focus on gene therapy products and associated vector production.
    • Supports in process characterization of cellular products as needed, either by directly supporting analytical characterization or working with internal QC analytical function.
    • Serves as a technical lead for process development projects, responsible for experimental design of process development studies, applying Quality by Design principles and Design of Experiment methodologies where appropriate.
    • Applies understanding of regulatory expectations to process development strategies.  Contributes to process risk assessments.  Justifies development strategies and experiment designs.
    • Responsible for trouble shooting, deviation investigation and product impact assessment for projects employing developed technology/processes.  Serves as an internal subject matter expert (SME).
    • Responsible for activities required for successful operation of assigned project area including:  Writing detailed experimental protocols, coordinating activities in the laboratory, developing Bill of Materials (BOM), executing and documenting experimental studies according to local Standard Operating Procedures (SOPs) or established practices, reviewing and reporting data, and contributing to technical reports.
    • Interacts internally with Manufacturing, Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management groups.  Interacts externally with clients, material/equipment vendors and commercial partners.
    • Reviews laboratory notebooks and logbooks.
    • Contributes to operations of the process development lab, including training of new employees. 
    • 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 WuXi AppTec Policies and Standard Operating Procedures.
    • Responsible for activities required for successful operation of assigned project area including:  Writing detailed experimental protocols, coordinating activities in the laboratory, developing Bill of Materials (BOM), executing and documenting experimental studies according to local Standard Operating Procedures (SOPs) or established practices, reviewing and reporting data, and contributing to technical reports.
    • Interacts internally with Manufacturing, Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management groups.  Interacts externally with clients, material/equipment vendors and commercial partners.
    • Authors and reviews laboratory notebooks and logbooks.
    • Contributes to operations of the process development lab, including training of new employees. 
    • 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 WuXi AppTec Policies and Standard Operating Procedures.

    Qualifications

    Experience / Education   

     

    • Bachelors, Masters or PhD in Biology, Immunology, Bioengineering or related field
    • 6 plus years of relevant experience with a Bachelors’ degree

    • 4 plus years of relevant experience with a Masters’ degree
    • 2 plus years of relevant experience with a PhD.or equivalent
    • Experience in upstream process development is required.  Familiarity with cell and gene therapy products is preferred, but experience with cell therapy research, process development, or manufacturing is required.
    • Experience with procedures for the isolation, transduction/activation, expansion and cryopreservation of gene modified patient derived cells.  Familiarity with handling of apheresis materials and / or whole blood and related cell processing equipment is preferred.
    • Experience with cell therapy automation technologies:  rocking bioreactors, closed system culture vessels, electroporation, cell washers, benchtop continuous centrifugation and separation technologies, and separation equipment for autologous products is a plus. 
    • Ability to perform complex mathematic and statistical calculations and data analysis, and to work with Excel and other scientific data analysis tools to collect and analyze data.
    • Ability to clearly express and exchange ideas by means of verbal and written communication.
    • Ability to work effectively as part of a team and exhibit effective interpersonal skills
    • Works in laboratory and production environments with potential exposure to occupational hazards including chemical cleaners, biohazardous materials, noise, mechanical and heat/cold energy.  Must be able to wear all required Personal Protective Equipment (PPE).  Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program. 

      Equal Opportunity Employer Minorities/Women/Veterans/Disabled

     

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