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 and monitors overall performance of aseptic technique ensuring compliance with standards
• 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 overall systems and 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 complex corrective maintenance
• Understands all operations, functions, capability of equipment and ancillary support to 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 and end-to-end expertise
• Possesses basic and fundamental facility start-up experience
• Has participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate and overseeing
• 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 in-house and offsite validation activities
• Provides input and reviews validation documentation
• Schedules, 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) and/or Super user on multiple systems
• Acts a member or Champion that helps to design the new system or of a systems improvement team
• Understands the concept of and has performed or experience with manufacturing processes and methods
• Oversees and monitors overall performance of manufacturing processes and methods ensuring compliance with standards
• Trains, coaches and mentors others on basic operations such as media preparation, thaw, passage and harvesting and specific unit operations and overall systems
• Identifies, understands and able to explain the 'why' of acceptable and unacceptable practices, is able to make on the spot corrections to performance
• Identifies process and method gaps and opportunities and implements improvements
• 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 complex 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, all unit operations and non-manufacturing SOPs and systems
• Participates, provides information in the development, authors and reviews technical documents such as non-conforming events and deviations
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates, leads and implements continuous improvement ideas
• Identifies, participates, suggests solutions and leads complex technical problem solving
• Identifies, suggests with options, recommends path forward and leads complex decision making sessions
• Delegates work assignments
• Accountable for schedule preparation, adjustments and performance of work assignments for team
• Participates, supports, assists as an SME, presents and represents during regulatory inspections and client audits
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Performs well under direct supervision and works independently on complex tasks and processes
• Leads and oversees the manufacturing process

Qualifications
• High School diploma and over 8 years of relevant experience or
• Associates'/Bachelor's (science preferred) degree with over 5 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.
• 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.