Manufacturing Associate II in Philadelphia, Pennsylvania

WuXi Apptec
Type

Research assistant / technician

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Overview

Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsibilities

  • Understands aseptic technique concepts
  • Able to operate and maintain equipment
  • Understands the basic operations and functions of equipment and is able to perform basic troubleshooting
  • Performs solution and material preparation
  • Possesses basic technical knowledge and background in the industry
  • Possesses basic and fundamental engineering and mechanical knowledge
  • Possesses basic and fundamental facility start-up experience
  • Has participated in facility start-ups
  • Participates on and performs technical transfer activities
  • Assists with the execution of validation activities
  • Receives and organizes materials
  • Uses most support systems (e.g. LIMS) with some demonstrated proficiency
  • Understands the concept of and has performed or experience with manufacturing processes and methods
  • Identifies and understands acceptable and unacceptable practices and is able to make on the spot corrections to performance
  • Collects, records, reviews, performs basic analysis and identify basic trends of scientific and process data per good document practices
  • Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and starts to understand ‘why’ behind the regulations
  • Follows and executes Standard Operating Procedures (SOPs)
  • Revises and authors simple SOPs
  • Follows and executes Batch Records (BRs)
  • Revises and authors simple BRs
  • Trains others on basic SOPs, equipment and unit operations
  • Participates and provides information in the development of technical documents such as non-conforming events and deviations
  • Possess basic computer skills and able to efficiently use basic Microsoft applications
  • Suggests and participates in continuous improvement ideas
  • Identifies, participates and suggests solutions to technical problems
  • Identifies, suggests and seeks out for decision making
  • Participates and supports regulatory inspections and client audits
  • Interacts on a minimal basis with groups that support manufacturing
  • Cross trains in other areas and may be utilized to perform above job functions across the entire site
  • Performs well under direct supervision and starts to work independently on basic tasks and processes
  • May be required to work Holidays and weekends
  • May be required to work Overtime
  • May be required to work outside of normal business hours
  • 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

Qualifications

  • Associates’/Bachelor’s (science preferred) degree with over 2 years of relevant or equivalent experience

 

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 Lab setting with Biohazards /various 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 40 lbs routinely
  • Ability to crouch, bend, twist, and reach
  • Ability to push/pull 40 lbs routinely/ often / occasionally
  • 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 perform activities with repetitive motions
  • Ability to climb Ladders / Stairs / Scaffolding
  • Ability to work in variable temperatures high to freezing
  • Inside/outside working conditions

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

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More Information

Type

Research assistant / technician

San%20Diego%2C%20United%20States

San Diego , United States