WuXi AppTec

  • Manager of Mycoplasma Testing

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4472
  • Overview

    Manages the Mycoplasma culture laboratory and staff to ensure day-to-day operations are being performed to meet the demands of testing operations.  The manager will be responsible for GMP Testing and production and maintenance of all internal cell banks and mycoplasma stocks.  The manager will have technical expertise in mycoplasma testing cell culture.  Laboratory design and commissioning will also be a primary function.

    Responsibilities

    • Manages the team for GMP Mycoplasma Culture Testing and staff responsible for  maintaining all internal stocks and cell lines
    • 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
    • Responsible for commissioning and planning of a new laboratory and creation of all standard operating procedures and test methods
    • 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 and provides technical support to staff
    • Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs
    • Accurately completes Test Methods and other required documentation according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs
    • Prepares protocols, final reports, investigations, and deviations as needed
    • Actively participate in continuous improvement opportunities
    • Implements key performance indicators for operations
    • 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 and assumes all associated responsibilities
    • Effectively interacts with clients
    • Maintains a laboratory notebook for Research & Development activities as required; reviews and signs laboratory notebooks
    • 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
    • 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 Manufacturing Practices
    • Other duties as assigned
    • May be required to assist in other departments

    Job Requirements:

     

    • Strong Mycoplasma and Cell Culture Expertise
    • Management Laboratory Operations
    • GMP laboratory commissioning

     

    Qualifications

    Experience / Education   

    • 5+  years relevant technical experience and min 5 years Managing people
    • BS/BA in Science related field preferred; or combination of relevant Experience & Education

     

    Knowledge / Skills / Abilities:

    • Expertise with Mycoplasma Testing and Cell Biology
    • Supervisory Skills and Lab Management
    • cGMP experience
    • 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 understand and follow verbal and demonstrated instructions
    • 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
    • Ability to work under limited supervision and to handle problems of a difficult nature
    • Ability to perform light physical work, lifting up to 20 pounds as needed, and performing activities such as repetitive motions
    • Clarity of vision at all ranges, depth perception, and ability to identify and distinguish colors
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)
    • Travel may be required

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Need help finding the right job?

    We can recommend jobs specifically for you! 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 Click here to get started.