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

Essential Job Functions:
• Understands aseptic technique concepts
• Has performed aseptic technique, is able to identify unacceptable practices and
make spot corrections to performance
• 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
• Performs material procurement activities
• Identifies, communicates and resolves material discrepancies
• 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)

Qualifications

• High School diploma and over 4 years of relevant experience or
• 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)

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.