WuXi AppTec

  • Supervisor Manufacturing

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4222
  • Overview

    Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

    Responsibilities

    • Understands aseptic technique concepts
    • Oversees and monitors overall performance of aseptic technique ensuring compliance with standards
    • Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance
    • Understands and is able to explain ‘why’ of acceptable and unacceptable aseptic technique practices
    • Trains, coaches, mentors and manages performance of others on basic aseptic operational techniques such as media preparation, thaw, passage and harvesting and overall systems and operations
    • Identifies aseptic technique gaps and opportunities and implements improvements across assigned programs
    • Able to operate and maintain equipment
    • Understands, determines and manages maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues
    • Coordinates complex corrective maintenance
    • Understands, teaches and coaches others on all operations, functions, capability of equipment and ancillary support to equipment and is able to perform complex troubleshooting
    • Drives sourcing and purchasing of standard, new and complex equipment
    • First point of escalation for equipment issues
    • Trains, coaches, mentors and manages performance of others performing solution and material preparation, analyzing results and resolving issues
    • Reviews and approves solution and material preparation results and resolves issues
    • First point of escalation for solution and material preparation issues
    • Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
    • Trains, coaches and mentors others in technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
    • Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end understanding
    • Trains, coaches, and mentors others with engineering and mechanical knowledge and how to apply to manufacturing area for unit operations and end-to-end understanding
    • Possesses basic and fundamental facility start-up experience
    • Trains, coaches, mentors others on facility start-up
    • Has participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate, delegate and manage across assigned programs
    • Provides input into facility design
    • Participates on and performs technical transfer activities
    • Trains, coaches, mentors and manages performance of technical transfer activities
    • Coordinates resources to support technical transfer runs
    • Provides feedback for facility fit
    • Reviews protocols and other technical transfer documents
    • Identifies and drives application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
    • Executes in-house and offsite validation activities
    • Trains, coaches, mentors and manages performance of validation activities
    • Provides input and review validation documents
    • Has working knowledge of validation requirements
    • Identifies validation gaps and needs across assigned programs
    • Trains, coaches and manages performance of scheduling, receipt and organization of materials
    • Forecast and performs material procurement activities
    • Reviews and finalizes material documents
    • Creates and/or approves CS forms
    • Owns change controls for new material implementation
    • Identifies, communicates and resolves material discrepancies
    • Uses all support systems (e.g. LIMS) with demonstrated proficiency and able to act as an subject matter expert (SME) and/or Super user on a system
    • Trains, coaches, mentors and manages performance of others use of support systems
    • Acts a lead, member or Champion that helps to design the new system or of a systems improvement team
    • Understands the concept of and has performed or experience with manufacturing processes and methods
    • Trains, coaches, mentors and manages overall performance of manufacturing processes and methods ensuring compliance with standards

    Qualifications

    Experience / Education:   

    • HS Diploma or equivalent required and
    • 5+  years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
    • BS/BA in Science related field preferred; or combination of relevant Experience & Education

     

    Knowledge / Skills / Abilities:

    • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
    • Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
    • Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
    • Works in production environment with exposure to latex and bleach.  Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors. 
    • Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program. 
    • Holiday and shift work often required based on manufacturing schedule as determined by Management.
    • 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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