WuXi AppTec

Manufacturing Associate I

US-PA-Philadelphia
Job ID
2017-3307

Overview

Responsible for manufacture of Master and Working Cell Banks and performing activities within the production facility to support manufacture of Cell & Gene Therapy products, and final product fills following cGMPs.

Responsibilities

  • Performs the manufacturing process for the GMP production of Master and Working Cell Banks.
  • Performs Cell Bank verification runs.
  • Performs support functions (e.g. Runner function) in the manufacture of Cell & Gene Therapies and final fill.
  • Adheres to Good Manufacturing Practices and standard operating procedures.
  • Contributes to the overall operations and to the achievement of departmental goals and objectives.
  • Performs basic Standard Operating Procedures (SOP’s) revisions and Solution Preparation Records as needed to accurately reflect manufacturing processes.
  • Completes production records and maintains clean room environment to comply with regulatory requirements.
  • Provides operational support for manufacturing activities including media/buffer preparation, cleaning activities, and equipment/materials staging.
  • Supports technical transfer of production technologies from client to clinical and commercial operations.
  • Edits Batch Production Records and Standard Operating Procedures as needed to accurately reflect process steps and capture process changes.
  • Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts. Examples include Standard Operating Procedure (SOP) or Batch Record revision or generalized trouble shooting of equipment.
  • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
  • Works under close supervision from supervisor or senior manufacturing personnel.
  • Provides operational support for (Specific Dept.) activities including (Ex. media/buffer preparation, cleaning activities, and equipment/materials staging/ Aseptic Technique).
  • 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 personnel.
  • Performs support functions (e.g. Runner function) in the (fill in Specific Dept.)
  • Ability to work in a team environment and independently as required
  • Maybe required to work Holidays and weekends
  • Maybe required to work Overtime ( Remove only for Exempt positions) 
  • 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
  • Other duties as assigned
  • May be required to assist in other departments

Qualifications

Experience / Education   

  • High School diploma and 1 year of relevant experience or an Associates’ degree
  • Associates’ degree or equivalent experience
  • Preferred (Ex. AALAC certifications, SPHR)

 

Knowledge / Skills / Abilities:

  • ≥ 2 Years in Cell Culture Technology with Associates degree or 0 - 2 Years in Cell Culture Experience in aseptic processing techniques a plus.
  • 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 (Mandarin)
  • Proficient in Microsoft (Excel, Word, Outlook)
  • Travel is required X% , Domestic/International, Daily / Overnight

 

Physical Requirements:

  • Must be able to work in an office environment with minimal noise conditions.
  • Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals (List specific Chemicals)
  • Must be able to wear appropriate PPE
  • Must be able to work in environment with variable noise levels
  • Ability to stand /Sit/walk for long periods of time
  • Ability to Lift X lbs routinely
  • Ability to crouch, bend, twist, and reach
  • Ability to push/pull X 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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