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Click here or scroll down to respond to this candidateCandidate's Name
Newtown, PAPHONE NUMBER AVAILABLEEMAIL AVAILABLEEXPERIENCE:Endo PharmaceuticalsHorsham, PASenior Manufacturing Specialist November2021-January 2023Authors, revises and reviews manufacturing and process equipment documentationAuthors investigation documentation and participates in/resolves manufacturing production events/non-conformances in timely mannerCreates and/or completes CAPA(s) resulting from manufacturing eventsAuthor and implement change requests to support changes to processing, batch records, and equipment, particularly scale-up processing, and process improvementAuthors/implements change controls associated with continuous improvement and supports equipment, process, and utilities.Assist with CCH process scale-up, development activities, new suite development and technology transfer projectsIdentify and support continuous improvement initiatives: Engages with supervisors and managers to optimize the manufacturing processFacilitate the upkeep of fermentation/purification owned equipment. Resolve equipment issues with engineering/facilities and contact vendors as needed.Works with Validation and leads process, equipment, and cleaning validation initiatives within the GMP facility as neededSupports validation efforts associated with manufacturing equipment and processesReviews batch records and logbooksProvide guidance and training to manufacturing specialists and other manufacturing associatesWorks in a hands-on capacity in the cGMP fermentation/purification and production support areas to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS)Performs and supports fermentation/purification process scale-up and all manufacturing production activitiesSuccessfully completed FAT (Factory Acceptance Test) and SAT (Site Acceptance Test) for Facility Equipment for scale-up for second suitePerforms engineering activities to ensure equipment functions to specifications for scale-up process including all CIPs and SIPsEnsures work is completed in compliance with approved SOPs, batch records and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followedProvides timely technical input to support ongoing operationsAssist in troubleshooting processes and equipment within the cGMP facilityAssists manufacturing leaders for inspection-readiness at all timesPerforms GEMBA walk thru montlyAha! Leadership Training CertifiedSupervisor- Upstream August 2020-Nov-2021Supervises team in hands-on capacity during GMP operations and authors daily production schedules and assists with all production activities.Provides timely technical input to support on-going operations and resolve manufacturing deviations/non- conformances.Troubleshoots processes and equipment within the GMP facility and performs documentation closeout activities to release processes and equipment for production as required.Supervises fermentation process scale-up or development activities as needed.Qualified Trainer on all Upstream Manufacturing Processes and SOPsAuthor shutdown schedules and ensure tasks are done on time and within compliance.Authors deviations and implements change controls and CAPAs associated with and support equipment, processes, and utilities.Authors, revises, and reviews manufacturing equipment, facility and utility documentation, including but not limited to: SOPs, forms, master batch records, and protocols.Executes protocols for process equipment and /or validationAssist QA, as required, with internal and external audits.Ensures manufacturing operations are established and maintained in compliance with all applicable regulations, guidelines and safety policies and procedures.Extensive knowledge of fermentation / upstream processing and equipment, and SAPKeeps track of all Upstream inventoryFrequent user of Coupa, Blue Mountain Regulatory (CAMS), Trackwise, and MasterControl systemsManufacturing Lead - Upstream March 2019-August 2020Leads manufacturing production activities to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment.Leads development, validation, and process improvement efforts and authors/implements change controls associated with fermentation and support equipment, processes, and utilities.Provides timely technical input to support ongoing operations.Works with cross-functional teams and leads process, equipment and cleaning validation initiatives within the GMP facility.Identifies and supports continuous improvement initiatives.Authors investigation documentation and participates/resolves manufacturing deviations/non-conformances.Troubleshoots processes and equipment and leads process, sterilization, and cleaning validation initiatives.Acts as qualified trainer for SOPs and procedures.Trains Manufacturing Associates of all levels.Advanced knowledge of cGMP practices, ICH guidelines, validation practices.Technical expert in fermentation / upstream processing.Advanced knowledge of automated or semi-automated fermenters, bioreactors, holding tanks, aseptic operations, seed scale-up, harvest equipment, and cleaning and sterilization procedures for biopharmaceutical products.Advanced knowledge of process validation practices for biopharmaceutical products and can author and lead process validation protocols and efforts.Manufacturing Associate II Upstream April 2015-March 2019Perform daily fermentation steps of cGMP manufacture of Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS).Work in hands-on capacity to operate fermenters (SIPs, CIPs), media preparation vessels, holding tanks, prepare media solutions, perform seed scale-up, sterilize (autoclave) and clean process equipment (washers).Lead process, equipment, and cleaning validation initiatives. Gather group to communicate daily tasks and weekly work.Assist with development work as needed.Author and revise manufacturing and process equipment documentation as necessary.Assist in the resolution of manufacturing deviations/non-conformances. Assist with troubleshooting processes and equipment.Keep track of results for validation spreadsheets.Performance trainer for all Manufacturing Activities as well as Aseptic Qualification TrainerOrder Logbooks, Batch records, and Media Forms.Stock gowning for the Manufacturing facility.Order materials and keep track of inventory for Upstream/Manufacturing.Ensure work is completed in compliance with:oApproved SOPs, Batch records, Controlled documentationoAll applicable regulations, guidelines, safety policies and ensuring procedures are followed.Manufacturing Associate I Upstream April 2010-April 2015Perform daily fermentation steps of cGMP manufacture of Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS).Work in hands-on capacity to operate fermenters (SIPs, CIPs), media preparation vessels, holding tanks, prepare media solutions, perform seed scale-up, sterilize (autoclave) and clean process equipment (washers).Lead process, equipment, and cleaning validation initiatives. Gather group to communicate daily tasks and weekly work.Assist with development work as needed.Revise manufacturing and process equipment documentation as necessary.Assist in the resolution of manufacturing deviations/non-conformances. Assist with troubleshooting processes and equipment.Keep track of results for validation spreadsheets.Order Logbooks, Batch records, and Media Forms.Stock gowning for the Manufacturing facility.Order materials and keep track of inventory for Upstream/Manufacturing.Ensure work is completed in compliance with:oApproved SOPs, Batch records, Controlled documentationoAll applicable regulations, guidelines, safety policies and ensuring procedures are followed.MedImmune, LLC Philadelphia, PAPharmaceutical Technical Specialist 1 July 2009-April 2010Manufacture Flumist and H1N1 Vaccines: procedures including:oThawing of product, stage, Environmental Monitoring (EM)(Personnel Plating), Aseptic Manufacturing Techniques, Controlled Facility Cleaning of Class 100- 10,000, Gowning Qualified of Controlled Areas, QC Responsibilities, Working with cGMPs and SOPs, Review and Edit SOPs, Evaluation of Media Sprayers for Media Fills, Materials TransferoExperience with Computer Software:MODA (Entering Data, Approver of Collected Data), Aegis, LMS, LIMSEDUCATION:TEMPLE UNIVERSITY, Philadelphia, PA January 2009Bachelor of Arts Major: Human BiologyBUCKS COUNTY COMMUNITY COLLEGE, Newtown, PA May 2002Associate of ArtsMajor: Liberal Arts and Sciences References available upon request |
