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.
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Pharmaceutical Manufacturing
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