Overview

Responsible for providing technical support to the 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

• Authors documentation which include but not limited toinvestigations/deviations/non-conforming events, action plans, CAPAs, changecontrols and protocols
• Provides and leads complex technical support and troubleshooting of routinemanufacturing, issue resolution, improvement, optimization and life cycle management
• Supports, performs and leads process technology transfer
• Performs and leads process monitoring, trending, comparability and controls
• Supports, performs and leads late stage studies, validation, characterization and robustness, production and regulatory filings in support of commercialization efforts
• Understands aseptic technique concepts
• Able to identify unacceptable practices and implement improvements
• Understands basic operations and functions of equipment
• Understands the corrective/preventative maintenance and calibration of equipment
• Works with vendor to understand and resolve issues
• Understands basic solution and material preparation
• Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry and in cell and gene therapy
• Possesses basic/fundamental and working application of engineering and mechanical knowledge and is able to apply end-to-end in the manufacturing area
• Ideally, possesses basic and fundamental facility start-up experience
• Understands the application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
• Possesses basic and fundamental understanding of validation activities and execution
• Possesses basic and fundamental understanding of material related activities and execution
• Subject Matter Expert (SME) on Master Control
• Possesses some proficiency on NovaTek
• Possesses some proficiency of support systems (e.g. LIMS)
• Understands the concept and working application of manufacturing processes and methods
• Possesses manufacturing end-to-end operational expertise
• Identifies, participates, understands and able to explain the 'why' of acceptable and unacceptable practices; is able to make suggestions with options and recommend path forward and leads basic sessions to improve performance
• Performs basic and complex analysis, interprets, and draws conclusion of scientific and process data per good document practices
• Follows compliance and regulatory requirements and current Good Manufacturing
• Practices (cGMPs) and understands 'why' behind the regulations.
• Identifies, communicates, addresses and improves simple and complex cGMP compliance and regulatory gaps and issues
• Follows and executes Standard Operating Procedures (SOPs)
• Revises, authors and provides comments as a reviewer to simple SOPs
• Improves the efficiency and execution of SOPs
• Improves the efficiency and right-first-time (RFT) of BR execution
• Trains others on SOPs, equipment and unit operations
• Trains others on Technical Operations SOPs and systems
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates, implements and leads continuous improvement ideas
• Identifies, participates, suggests solutions and leads basic and complex technical problems
• Identifies, participates, suggests with options, recommends path forward and leads basic and complex decision making
• Prepares work assignment schedules
• Starts to delegate work assignments
• Participates, supports, presents and represents as an SME during regulatory inspections and client audits
• Interacts frequently with groups
• Regularly coordinates and deals with problems with groups
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Works independently on complex tasks and processes
• Possesses lean/six sigma knowledge and experience
• May be required to work Holidays and weekends
• May be required to work outside of normal business hours
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Other duties as assigned
• May be required to assist in other departments

Qualifications

• 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
• BS/BA in Science related field preferred; or combination of relevant Experience & Education
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
• 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)
• Ability to stand /Sit/walk for long periods of time
• Ability to Lift 40 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 40 lbs routinely/ often / occasionally
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs / Scaffolding
• Ability to work in variable temperatures high to freezing
• Inside/outside working conditions

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