Senior Manufacturing Associate

Wuxi Apptec Philadelphia , PA 19107

Posted 2 months ago

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

  • Oversees performance of aseptic technique

  • Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance

  • Understands and is able to explain 'why' of acceptable and unacceptable aseptic technique practices

  • Trains, coaches and mentors others on basic aseptic operational techniques such as media preparation, thaw, passage and harvesting and specific unit operations

  • Identifies aseptic technique gaps and opportunities and implements improvements

  • Able to operate and maintain equipment

  • Understands and determines maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues

  • Coordinates basic corrective maintenance

  • Understands all operations, functions and capability of equipment and is able to perform complex troubleshooting

  • Supports sourcing and purchasing of standard, new and complex equipment

  • Performs solution and material preparation, analyzing results and resolving issues

  • Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy

  • Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational expertise

  • Possesses basic and fundamental facility start-up experience

  • Has participated in facility start-ups and may lead a subteam to support

  • Participates on and performs technical transfer activities

  • Helps with application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer

  • May be required to work Holidays and weekends

  • May be required to work Overtime

  • May be required to work outside of normal business hours

Qualifications

Job Requirements:

  • High School diploma and over 8 years of relevant experience or

  • Associate's/Bachelor's (science preferred) degree with over 4 years of relevant or equivalent experience

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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Senior Manufacturing Associate

Wuxi Apptec