WuXi AppTec

  • Manager, Viral Clearance

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4192
  • Overview

    Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the Viral Clearance lab. Manages and trains resources that support Viral Clearance laboratory operations. Strong understanding of cell culture processes. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives. Performs and directs assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Acts as Study Director as needed.

    Responsibilities

    • Manages, plans and reviews operations for assigned staff, including scheduling and capacity
    • Recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems
    • Demonstrates innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures
    • Provides technical support to clients on Viral Clearance study design
    • Effectively communicates and defends science through written and verbal communication
    • Provides training on areas of technical expertise and compliance issues relevant to the lab setting
    • Conducts and directs assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
    • Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
    • Prepares and revises technical documents (Client Protocols, SOPs, etc.).
    • Conducts critical review of results and reports data appropriately
    • As assigned by Management, supervises personnel and assumes all associated responsibilities
    • As assigned by Management, acts as Study Director, and/or Technical Reviewer for Viral Clearance studies and assumes all associated responsibilities
    • Effectively interacts with clients
    • Follows all general and laboratory SOPs
    • Communicates with supervisor and other colleagues re: daily lab activities
    • 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
    • May be required to work Holidays and weekends
    • May be required to work Overtime
    • May be required to work outside of normal business hours
    • 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
    • Other duties as assigned
      May be required to assist in other departments


    Qualifications

    Experience / Education:

     

    • 5+ years relevant technical experience and
    • Minimum of 2 years in a Lead/Leadership/Supervisory Role
    • BS/BA in Science related field preferred; or combination of relevant Experience & Education
    • Experience in Downstream Process Development and lab management (preferably high volume in a GMP environment)
    • Experience with AKTA systems and software is required
    • Knowledge of Viral Validation studies is preferred


    Knowledge / Skills / Abilities:

    • Effective multi-tasking skills and time management required
    • Ability to evaluate technical data and record data accurately and legibly
    • Ability to accurately and reproducibly perform complex mathematical and statistical calculations
    • Ability to use judgment as dictated by complexity of situations
    • Ability to follow verbal and demonstrated instructions
    • Ability to clearly understand, express and exchange ideas by means of oral and written

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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