Senior Bioprocessing Associate

Overview

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. 

  

Our benefits include:

• 401K matching
• PTO
• Employee discount programs
• Medical, dental and vision insurance
• and much more

Responsibilities

• Responsible for providing support in performance of activities within production facilities to support the manufacture of Master and Working Cell Banks Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

• Understands aseptic technique concepts and has performed aseptic technique.• Is able to identify unacceptable practices, make spot corrections to performance and implement improvements• Understands and is able to explain ‘why’ of acceptable and unacceptable aseptic technique practices• Supports design of aseptic operational techniques such as media preparation, thaw, passage, harvesting and overall systems and operations• Identifies, participates, suggests solutions and leads complex technical problem solving• Understands and teaches others on all operations, functions, capability of equipment and ancillary support to equipment and is able to perform complex troubleshooting• Able to operate and maintain equipment and coordinate complex corrective maintenance• Understands, determines and manages maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues• Drives sourcing and purchasing of standard, new and complex equipment• Primary point of escalation for equipment issues• Trains others performing solution and material preparation, analyzing results and resolving issues• Reviews solution and material preparation results and resolves issues• Primary point of escalation for solution and material preparation issues• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy• Trains 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 others with engineering and mechanical knowledge and how to apply to manufacturing area for unit operations and end-to-end understanding• Possesses basic and fundamental facility start-up experience and trains others on facility start-up• Has participated in facility start-ups and may lead a sub team that requires leading, planning, coordinate, delegate and manage across assigned programs• Provides input into facility design and provides feedback for facility fit• Leads, participates on and performs technical transfer activities while training others and managing performance• Coordinates resources to support technical transfer runs and reviews protocols and other technical transfer documents• Identifies and drives 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 and trains and manages the performance of validation activities• Has working knowledge of validation requirements and provides input, reviews and executes validation documents• Identifies validation gaps and needs across assigned programs• Supports performance of scheduling, receipt and organization of materials and forecast and supports material procurement activities• Reviews and finalizes material documents, creates and/or approves CS forms and owns change controls• Uses all support systems (e.g. LIMS) with demonstrated proficiency and is able to act as subject matter expert (SME) and/or Superuser on a system and train others• Acts a 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, interprets data and draws conclusions• Supports overall performance of manufacturing processes and methods ensuring compliance with standards• Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific• 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.• 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) and trains others who execute SOPs and BRs• Revises, authors and reviews simple and complex SOPs• Standardizes, aligns, reviews and approves SOPs• Improves the efficiency and execution of SOPs• Revises, authors and reviews simple and complex BRs• Improves the efficiency and right-first-time (RFT) of BR execution• Standardizes, aligns, reviews and approves BRs• Trains others on SOPs, equipment, all unit operations and non-manufacturing SOPs and systems• Authors, reviews and approves technical documents such as non-conforming events and deviations• Makes suggestions to the training program and teaches others participating, provides information and authors technical documents• Possess basic computer skills and able to efficiently use basic Microsoft applications• Suggests, participates, leads, implements and champions continuous improvement ideas while teaching, coaching and mentoring others• Identifies, participates, suggests solutions and leads complex technical problem solving and prioritizes escalations while teaching and mentoring others• Primary point of escalation for technical problems• Identifies, suggests with options, recommends path forward and leads complex decision making sessions as well as teaching, coaching and mentoring others• Primary point of escalation for issues that require decisions• Participates, supports, assists as an SME, leads, resolves conflict, 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, may be required to assist in other departments• Delivers performance efficiencies to impact assigned program and site specific departmental gross margin and has basic financial knowledge and acumen• Performs well under direct supervision and works independently on complex tasks and processes

Qualifications

• HS Diploma or equivalent required, BS/BA in Science related field preferred; or a combination of relevant Experience & Education• 5 years of relevant technical experience with a minimum of 2 years in a Lead/Leadership/Supervisory role

 

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.