WuXi AppTec

Manufacturing Associate III

US-PA-Philadelphia
Job ID
2017-3166

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 necessaryProvides 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

 

Education:

  • Associates degree with 3-5 years experience
  • Bachelors’ degree in Biology, Chemistry or other science related field with at least 2 years of experience

 

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, cleanroom hoods) 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 (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 manufacturing setting with exposure to biohazards and 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
  • Must be able to perform activities with repetitive motions

 

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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