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).
* Authors documentation which include but not limited to investigations/deviations/non-conforming events, action plans, CAPAs, change controls and protocols• Provides and leads complex technical support and troubleshooting of routine manufacturing, 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 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
* 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
New hires must be fully vaccinated against COVID-19 and provide proof of vaccination or receive an approved medical or religious exemption from Human Resources. This offer is contingent upon WuXi ATU verifying your vaccination status or approving an exemption request prior to your start date. If you wish to be considered for a medical or religious exemption, request an exemption by notifying WuXi as soon as possible, but no later than one week before your start date.
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