WuXi AppTec

  • Manufacturing Associate III

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3557
  • Overview

    Responsible for manufacture of the following: Cell Banks, Viral Vectors, Cell Therapy, and Gene Therapy products following Current Good Manufacturing Practices

    Responsibilities

    • Performs manufacturing processes for the GMP production. Operational assignment will depend upon specific background/skills suitable for specific product types.  Processes may include but are not limited to:
    • Cell culture utilizing aseptic technique: cell banking, cell expansion using flasks, cell stacks/HyperStacks, and bioreactors.
    • Purification processing: Clarification, TFF and chromatography
    • Aseptic filling: manual and semi-automated
    • Solution and media preparations
    • Support activities: cleaning, staging and transfer of materials, wash and steam sterilization of parts.
    • Adheres to Good Manufacturing Practices and standard operating procedures.
    • Demonstrates technical knowledge and contributes to the overall operations and to the achievement of departmental goals and objectives.
    • Understands the importance of the regulatory compliance requirements for the production of biologics.
    • Participates in manufacturing operations in assigned area per cGMPs.
    • Authors and revises Standard Operating Procedures (SOP’s) revisions, Batch Records, and Solution Preparation Records as needed to accurately reflect manufacturing processes.
    • Adheres to procedures to ensure to maintain the clean room environment to comply with regulatory requirements.
    • Ensures manufacturing personnel comply with standard operating procedures and master production records.                                    
    • Possesses sound scientific knowledge and understanding of manufacturing processes and uses this skill set to routinely monitor manufacturing processes and recognize potential process issues as they arise.
    • Reviews applicable technical documents to ensure accuracy and completion.
    • Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations.
    • Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary.
    • Provides training and operational guidance in manufacturing processes to newer employees.
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
    • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
    • Works under close supervision from supervisor or senior manufacturing personnel.
    • Ability to work in a team environment and independently as required.
    • Maybe required to work holidays, weekends, and overtime.

    Qualifications

    Experience / Education:  

    • ≥ 5 Years in cell culture experience with Associates degree
    • 2-3 Years with Bachelors’ degree in Biology, Chemistry or other science related field

    Knowledge / Skills / Abilities:

    • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations
    • 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 (Mandarin)
    • Proficient in Microsoft (Excel, Word, Outlook)

    Physical Requirements:

    • Must be able to work in an office environment with minimal noise conditions
    • Must be able to work in Lab setting with Biohazards /various Chemicals
    • Must be able to wear appropriate PPE
    • Must be able to work in a cleanroom environment
    • Must be able to work in environment with variable noise levels
    • Ability to stand /sit/walk for long periods of time
    • Ability to Lift 50 lbs routinely
    • Ability to crouch, bend, twist, and reach
    • Ability to push/pull 50 lbs routinely/ often / occasionally
    • Clarity of Vision
    • Ability to identify and distinguish colors
    • Must be able to perform activities with repetitive motions
    • Ability to climb Ladders / Stairs / Scaffolding
    • Ability to work in variable temperatures high to freezing

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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