WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need. 

Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning. 

As the Senior Supervisor Technical Operations, you will be 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).

• Understands aseptic technique concepts
• Monitors overall performance of aseptic technique ensuring compliance with standards
• Identifies aseptic technique gaps and opportunities and implements improvements across assigned programs
• 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
• Trains, coaches, mentors and manages performance of others performing 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
• Trains, coaches and mentors others in 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 understanding
• Trains, coaches, and mentors others with engineering and mechanical knowledge and how to apply to manufacturing area for unit operations and end-to-end understanding
• Ideally, possesses basic and fundamental facility start-up experience
• Ideally, trains, coaches, mentors others on facility start-up
• Ideally, has participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate, delegate and manage across assigned programs
• Ideally, provides input into facility design
• Trains, coaches, mentors and manages performance of technical transfer activities
• Reviews protocols and provides input on other technical transfer documents
• Understands the application of GMP concepts as the process develops during phases of technical transfer
• Trains, coaches, mentors and manages performance of validation activities
• Provides input and review validation documents
• Has working knowledge of validation requirements
• Identifies validation gaps and needs across assigned programs
• Possesses basic and fundamental understanding of material related activities and execution
• Subject Matter Expert (SME) on Master Control
• Internal SME on some support systems (e.g. LIMS)
• Trains, coaches, mentors and manages performance of others use of support systems
• Acts as lead, 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
• Trains, coaches, mentors and manages overall performance of manufacturing processes and methods ensuring compliance with standards
• 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
• Understands processes and recommends product/lot impact
• Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific and teaches, coaches, mentors and manages performance of others to do the same
• Performs basic and complex analysis, interprets, and draws conclusion 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 train, coach, mentor and manage performance of others to do the same
• Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across assigned programs and site specific
• Follows and executes Standard Operating Procedures (SOPs)
• Trains, coaches, mentors and manages performance of others who execute SOPs
• Revises, authors and reviews simple and complex SOPs
• Standardizes and aligns SOPs
• Improves the efficiency and execution of SOPs
• Reviews and approves SOPs

Qualifications

• HS Diploma or equivalent required and
• 7+ years relevant technical experience and min 3 years in a Lead/Leadership/Supervisory Role
• BS/BA in Science related field preferred; or combination of relevant Experience & Education

Knowledge / Skills / Abilities:

• • 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 work in Lab setting with  Biohazards /various Chemicals
  • Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
  • 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 (Mandarin)
  • Proficient in Microsoft (Excel, Word, Outlook)