WuXi AppTec

  • Manager Technical Operations

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4444
  • Overview

    Responsible for managing day-to-day Technical Operations in support of Manufacturing.  Scope includes management of teams responsible for:

    Quality systems which include but not limited to investigations/deviations/non-conforming events, action plans, CAPAs, change controls and protocols

    • Training
    • Technical support
    • Process technology transfer

    Responsibilities

    • Support daily operations in the manufacture of the following: Cell Banks, Viral Vectors, Cell Therapy, and Gene Therapy products following Current Good Manufacturing Practices.
    • Team formation
    • Build a technical operations team focused on supporting and improving operational performance in aspects of process and human performance
    • Develops team technically, to investigate using various tools, with verbal and written communication and with lean and six sigma methodology
    • Staff and train employees within area of responsibility.  Utilizes effective resource management using cross training and a flexible, creative approach
    • Develop processes to manage metrics as a means to monitor and improve performance
    • Recommends hire/transfer/promotion/discharge and salary changes and acts on problems of direct reports
    • Conducts employee performance appraisals in a timely and objective manner
    • Quality Systems
    • Reviews quality systems to ensure compliance, robustness and to identify areas of opportunity for coaching and improvement
    • Participates, coaches and may lead complex quality system performance
    • Develops systems and metrics to coordinate and communicate in order to execute quality systems of good quality that meet time expectations
    • Prepared to present quality systems during regulatory inspections and audits
    • Training
    • Oversees the coordination, design, documentation and delivery of training for all manufacturing department personnel to ensure compliance and enable production performance
    • Oversee the development of the training program that manages the lifecycle of employees
    • Ensures training materials are created and updated in accordance with learning best practices and technical changes
    • Helps to evaluate training program for effectiveness using trainee feedback, area management discussions, deviation reports, etc. as sources of information and implements improvements
    • Technical support
    • Create and develop a team that supports manufacturing in the safe, compliant and cost effective production to deliver upon client contracts
    • Process technology transfer
    • Helps support manufacturing in the evaluation of incoming client projects/program to WuXi and from process development to manufacturing
    • Helps support manufacturing in the enhancement of service offerings
    • Lead and support initiatives around process improvements to increase performance that ensures products and services meet quality standards.
    • Measure and analyze manufacturing information and data for the purpose of developing and executing improved performance
    • Manage and support both internal and external resources to plan and execute improvement projects
    • Utilizes lean principles and six sigma methodology to solve problems, and develops these problem solving skills in others
    • 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 Laboratory Practices and Good Manufacturing Practices
    • 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
    • Other duties as assigned
    • May be required to assist in other departments

    Qualifications

    Experience / Education   

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

     

    Knowledge / Skills / Abilities:

    • Has a detailed process and equipment knowledge of Cell Processing
    • Has a thorough understanding of cGMP requirements for a clinical and commercial scale manufacturing facility.
    • Excellent communication skills, both oral and written.
    • Demonstrated leadership skills.
    • Ability to work effectively as part of a team.
    • Ability to use judgment as dictated by complexity of situation.
    • Ability to evaluate technical data and write technical documents.
    • Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
    • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
    • Ability to record data accurately and legibly.
    • Ability to express or exchange ideas by means of the spoken word.
    • Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
    • Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks.
    • Must have the ability to stand for long periods.
    • Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).
    • Develop / maintain Manufacturing schedule.
    • Allocate suites in the MFG space for production activities.
    • Manage process improvements.
    • Manage Raw material / Consumables orders/release.
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English (Mandarin)
    • Proficient in Microsoft (Excel, Word, Outlook)
    • Travel is required X% , Domestic/International, Daily / Overnight

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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