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
• 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 others on basic aseptic operational techniques such as media preparation, thaw, passage and harvesting
• Able to operate and maintain equipment
• Understands the maintenance of equipment
• Understands most operations and functions of equipment and is able to perform major troubleshooting
• Identifies needs for corrective maintenance
• Assists with sourcing and purchasing of standard equipment
• Performs solution and material preparation
• Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry
• Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area
• Possesses basic and fundamental facility start-up experience
• Has participated in facility start-ups and may participate on a subteam to support
• Participates on and performs technical transfer activities
• Provides feedback for facility fit
• Helps with application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
• Executes validation activities
• Provides input and reviews validation documentation
• Scheduled, receives and organizes materials
• Performs material procurement activities
• Creates and revises material documents
• Creates CS forms
• Identifies, communicates and resolves material discrepancies
• Uses all support systems (e.g. LIMS) with demonstrated proficiency and able to act as an subject matter expert (SME) on a system
• Understands the concept of and has performed or experience with manufacturing processes and methods
• Trains others on basic operations such as media preparation, thaw, passage and harvesting
• Identifies, understands and able to explain the 'why' of acceptable and unacceptable practices, is able to make on the spot corrections to performance
• Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices
• Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands 'why' behind the regulations. Able to coach and mentor others to do the same
• Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues
• Follows, executes, authors, and improves the efficiency and execution of Standard Operating Procedures (SOPs) and Batch Records (BRs)
• Trains others on SOPs, equipment and all unit operations
• Participates, provides information in the development of and authors basic technical documents such as non-conforming events and deviations
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates and implements continuous improvement ideas
• Identifies, participates and suggests solutions to technical problems
• Identifies, suggests with options and seeks out for decision making
• Starts to delegate work assignments
• Participates, supports and assists as an SME during regulatory inspections and client audits
• Interacts on an occasional basis with groups that support manufacturing
• Starts to coordinate internally and deal with problems with groups that support manufacturing
• Performs well under direct supervision and works independently on basic tasks and processes

Qualifications
• High School diploma and over 6 years of relevant experience or
• Associates'/Bachelor's (science preferred) degree with over 3 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.