WuXi AppTec

  • Associate Research Scientist, Cell Potency

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3913
  • Overview

    Designs and executes research & development studies, assay qualifications and test article validations under limited supervision. Drafts test methods and clearly documents all experiments according to SOPs and cGMP guidelines. Acts as a Technical Reviewer and assay trainer.  Partners with Testing Operations during assay transfer and validation activities.  Participates in client calls and face to face meetings with assistance by departmental senior staff.

    Responsibilities

    • Designs and executes R&D studies under limited supervision.
    • Executes QP and VPs and other GMP methods. Drafts QP or VP under minimal supervision of supervisor or technical lead. 
    • Drafts test methods/RPs/SOPs. Drafts client protocols under minimal supervision
    • Participates in assay transfers to Operations. Serves as trainer for inter- and intra-departmental staff
    • Writes research and development reports and ensures data are reported clearly and accurately.
    • Reports observations of ongoing tests to appropriate internal staff and clients, as needed.
    • Author and execute IQOQ, author equipment SOP, as needed.
    • Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
    • Demonstrates solid proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
    • Conducts critical review of results and interprets the data. Draws conclusions and plans next steps for assay development or troubleshooting.
    • Serves as technical reviewer and LIMS tech manager.
    • Participates in client calls and face to face meetings with assistance by departmental senior staff.
    • General lab housekeeping, ordering reagents and materials, initiate work orders, as needed
    • Initiate and track change controls
    • Author and execute IQOQ, author equipment SOP, as needed.
    • Investigates and responds to equipment OOTs
    • Performs equipment PMs, as needed.
    • Responsible for REES/ELPRO monitoring and response
    • Completes all required training (i.e. safety, equipment etc.).
    • Ability to work in a team environment and independently as required
    • Maybe required to work Holidays and weekends
    • 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 Manufacturing Practices
    • May be required to assist in other departments

    Qualifications

    Experience / Education   

    • Bachelor's degree + 4 years relevent, hands-on lab experience or Master's Degree + 2 years relevant experience

     

    Knowledge / Skills / Abilities:

    • Experience with gene therapy vectors and/or gene mediated cell therapy highly desirable.
    • Aseptic technique, mammalian cell culture and cell based potency testing experience required.
    • Experience in a cGMP environment is highly desirable.
    • Ability to use judgment as dictated by complexity of situation.
    • Ability to work under limited supervision and to handle problems of a more difficult nature.
    • Ability to accomplish the described duties through the use of appropriate laboratory equipment and computer equipment and software.
    • Ability to record data accurately and legibly
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)

     

    Physical Requirements:

    • Must be able to work in an environment with variable noise conditions.
    • Must be able to work in Lab setting with exposure to Biohazards / Chemicals
    • Must be able to wear appropriate PPE
    • Ability to stand /Sit/walk for long periods of time
    • Ability to crouch, bend, twist, and reach
    • Clarity of Vision
    • Ability to identify and distinguish colors, preferred
    • Must be able to perform activities with repetitive motions
    •  

    An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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