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 matchingPTOEmployee discount programsMedical, dental and vision insuranceand much moreThe Lead Manufacturing Associate is 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 conceptsOversees and monitors overall performance of aseptic technique ensuring compliance with standardsHas performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performanceUnderstands and is able to explain ‘why’ of acceptable and unacceptable aseptic technique practicesTrains, coaches and mentors others on basic aseptic operational techniques such as media preparation, thaw, passage and harvesting and overall systems and operationsIdentifies aseptic technique gaps and opportunities and implements improvementsAble to operate and maintain equipmentUnderstands and determines maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issuesCoordinates complex corrective maintenanceUnderstands all operations, functions, capability of equipment and ancillary support to equipment and is able to perform complex troubleshootingSupports sourcing and purchasing of standard, new and complex equipmentPerforms solution and material preparation, analyzing results and resolving issuesPossesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapyPossesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end expertisePossesses basic and fundamental facility start-up experienceHas participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate and overseeingParticipates on and performs technical transfer activitiesProvides feedback for facility fitHelps with application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transferExecutes in-house and offsite validation activitiesProvides input and reviews validation documentationSchedules, receives and organizes materialsPerforms material procurement activitiesCreates and revises material documentsCreates CS formsIdentifies, communicates and resolves material discrepanciesUses 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 systemsActs a member or Champion that helps to design the new system or of a systems improvement teamUnderstands the concept of and has performed or experience with manufacturing processes and methodsOversees and monitors overall performance of manufacturing processes and methods ensuring compliance with standardsTrains, coaches and mentors others on basic operations such as media preparation, thaw, passage and harvesting and specific unit operations and overall systemsIdentifies, understands and able to explain the ‘why’ of acceptable and unacceptable practices, is able to make on the spot corrections to performanceIdentifies process and method gaps and opportunities and implements improvementsCollects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practicesCommunicates with internal and external stakeholders scientific and process data and recommends path for forward processingFollows 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 sameIdentifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issuesFollows, 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 systemsParticipates, provides information in the development, authors and reviews technical documents such as non-conforming events and deviationsPossess basic computer skills and able to efficiently use basic Microsoft applicationsSuggests, participates, leads and implements continuous improvement ideasIdentifies, participates, suggests solutions and leads complex technical problem solvingIdentifies, suggests with options, recommends path forward and leads complex decision making sessionsDelegates work assignmentsAccountable for schedule preparation, adjustments and performance of work assignments for teamParticipates, supports, assists as an SME, presents and represents during regulatory inspections and client auditsCross trains in other areas and may be utilized to perform above job functions across the entire sitePerforms well under direct supervision and works independently on complex tasks and processesLeads and oversees the manufacturing process Qualifications High School diploma and over 8 years of relevant experienceOR
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 skillsNeed to be able to read, write and understand EnglishProficient 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.
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