Manufacturing Operations Coordinator
WuXi AppTec - Philadelphia, PA
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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 moreThe Manufacturing Operations Coordinator is responsible for coordinating manufacturing activities for those who produce and support the manufacture of Master and Working Cell Banks, Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).Plans, coordinates, tracks, communicates, follows-up and reports out on the use, cleaning, preventative maintenance, corrective maintenance and calibration requirements while working with Manufacturing, Facilities, Metrology and vendorsAssists with sourcing and purchasing of equipmentPlans, coordinates, tracks, communicates, follows-up and reports out on solution and material preparationPossesses basic industry knowledge, ideally background in the pharmaceutical and biotechnology industry or cell and gene therapyPossesses basic and fundamental engineering and mechanical knowledgePlans, coordinates, tracks, communicates, follows-up and reports out on facility activities including start-upPossesses basic and fundamental understanding of technical transfer activitiesHelps coordinates resources for and plans, coordinates, tracks, communicates, follows-up and reports out on technical transfer progress as it relates to manufacturing area readinessPlans, coordinates, tracks, communicates, follows-up and reports out on validation activitiesPlans, forecasts, coordinates, tracks, communicates, follows-up and reports out on orders, receipts, documents and procurement of materials, material discrepancies and material related activities while working with Supply ChainFirst point of escalation for material related issuesProficiency on Great PlainsPossesses basic and fundamental understanding of support systems (e.g. LIMS)Understands the concept of manufacturing processes and methodsFollows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations.Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issuesFollows and executes Standard Operating Procedures (SOPs)Tracks, communicates, follows up on and reports out the status of SOPsTracks, communicates, follows up on and reports out the status of Batch Records (BRs)Compiles, prepares and presents metrics/KPIsPossess basic computer skills and able to efficiently use basic Microsoft applicationsSuggests, participates and implements continuous improvement ideasPlans, forecasts, models, coordinates, tracks, communicates, follows-up and reports out on work assignmentsPlans, coordinates, tracks, communicates, follows-up and reports out on regulatory inspections and client auditsInteracts frequently with groupsRegularly and frequently coordinates with groupsIdentifies and works to resolve issues and relations with groups that support manufacturingCross trains in other areas and may be utilized to perform above job functions across the entire sitePerforms well under minimal supervision and starts to work independently on basic tasks and processeIdentifies and prioritizes escalationsHas basic financial knowledge and acumenForecasts and models financialsMay be required to work Holidays and weekendsMay be required to work OvertimeMay be required to work outside of normal business hoursContributes to the overall operations and to the achievement of departmental goalsPerform 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 PracticesOther duties as assignedMay be required to assist in other departmentsExperience/Education:High School diploma and over 6 years of relevant experience orAssociates’/Bachelor’s (ideally science) degree with over 3 years of relevant or equivalent experienceKnowledge/Skills/Abilities:Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.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.Proficient in Oral & Written communication skillsNeed to be able to read, write and understand EnglishProficient in Microsoft (Excel, Word, Outlook)Physical Requirements:Must be able to work in an office environment with minimal noise conditions.Must be able to work in Lab setting with Biohazards /various ChemicalsMust be able to wear appropriate PPEMust be able to work in environment with variable noise levelsAbility to stand /Sit/walk for long periods of timeAbility to Lift 40 lbs routinelyAbility to crouch, bend, twist, and reachAbility to push/pull 40 lbs routinely/ often / occasionallyClarity of VisionAbility to identify and distinguish colorsMust be able to perform activities with repetitive motionsAbility to climb Ladders / Stairs / ScaffoldingAbility to work in variable temperatures high to freezingInside/outside working conditionsThis job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.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.
Created: 2024-06-24