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).
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
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
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.