WuXi AppTec

  • Principal Scientist

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4330
  • Overview

    Independent scientist contributing to the development of early and late stage clinical and commercial manufacturing processes, with a focus on large scale viral vector production.  This position will manage 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 to tech transfer and manufacturing activities as necessary.  Demonstrates strong oral and written communication skills, and leads client-facing activities for viral vectors.  Contributes to the achievement of company and departmental goals and objectives. Experience in upstream process development or manufacturing is required.

     

     

    Responsibilities

    • Serves as a functional team lead for subject matter area.  Manage a team of scientist from all levels of the scientific ladder.
    • Leadership skills such as personnel management and development, cross functional interactions, accountability to lead and advise multiple technical programs, interfacing with client senior management, proposal writing and business development, and resource appropriation are highly preferred.
    • 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.
    • Possesses knowledge of viral vector production at small and/or large scale adherent systems required.  Experience with suspension cultures and/or bioreactors 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. 
    • Need to be able to read, write and understand English
    • Proficient in Microsoft Office products (Excel, Word, Outlook)
    • Responsible for successful process development and technology transfer of viral vector products.
    • Supports in-process characterization of cellular products as needed, either by directly supporting analytical characterization or working with internal QC analytical function.
    • 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.
    • Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
    • Plans, monitors, and appraises direct reports including performance competencies, goals & job results
    • Coaches, counsels, and conducts disciplinary actions for direct reports
    • Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity  standards
    • Contributes to the overall operations and to the achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices

     

    Qualifications

    Experience / Education   

    • 6-10 years of relevant experience with a Bachelors’ degree
    • 4-8 years of relevant experience with a Masters’ degree
    • 2-4 years of relevant experience with a PhD.or equivalent
    • Bachelors, Masters or PhD in Biology, Biochemistry, Immunology, Bioengineering or related field.

     

    Knowledge / Skills / Abilities:

    • Experience in upstream, downstream or formulation process development is required.  Familiarity with cell and gene therapy products is preferred, but experience with protein purification/formulation will also be considered.
    • 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.
    • Leadership skills such as personnel management, cross functional interactions, leadership team, owning multiple technical programs, steering the technical, interfacing with client senior management, developing work orders, and resource appropriation are highly preferred.
    • Possesses knowledge of viral vector production at small and/or large scale.  Experience with purification of viral vectors is strongly preferred, including chromatography, centrifugation, filtration and TFF.  Experience with wave or stirred tank bioreactors 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. 
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)

      Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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