WuXi AppTec

Manufacturing Associate I *

Job Locations US-PA-Philadelphia
Job ID
2017-3369

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.
  • Contributes to the overall operations and to the achievement of departmental goals and objectives.
  • Revise 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.
  • Supports technical transfer of production technologies from client to clinical and commercial operations.
  • 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.
  • Normally receives detailed 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

Qualifications

Experience / Education:  

  • ≥ 2 Years in cell culture experience with Associates degree
  • 0-1 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
  • 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
  • Must be able to perform activities with repetitive motions

 Equal Opportunity Employer Minorities/Women/Veterans/Disabled 

 

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