Vipan Kumar Email & Phone Number

Plainfield, Nj, Us

Lawrence Township, Nj, Us

Ensured 100% compliance with regulatory standards by managing CAR-T cell therapy drug product disposition and batch record reviewsprocess.Guided Raw Material and Intermediates Disposition, streamlined the Batch Record and Document Issuance process.Developed schedules for QA Disposition team, significantly improving project completion timelines.Led Change Controls within Quality Management System and spearheaded the development of GDP Refresher training for Manufacturingdepartment.Resolved Quality issues, enhancing the product release process, and ensured manufacturing compliance.Collaborated with supply chain to address deficiencies, improving overall compliance and efficiency.Enhanced QA team's proficiency by creating training materials and aligning Quality Assurance Disposition processes.Facilitated internal communication on batch discrepancies and nonconformance through SharePoint, boosting issue resolution efficiency.

Lawrence Township, Nj, Us

Manage daily activities while supporting clinical manufacturing process for CAR-T cell therapyResponsible for disposition activities for site manufactured CAR-T drug product and raw materials.Ensure manufacturing compliance with applicable procedures and batch recordsReviewed CAR-T records for PBMC Isolation, wash, cryopreservation, lentiviral transduction, cell culture maintenance, final drug product and all associated ancillary documents.Verified transported Leukapheresis with the accompanied documents for accuracy and completion prior to releaseWorked with supply Chain and Operations teams to correct any noted deficiencies and inefficiencies which could adversely impact complianceUtilized SharePoint to address and communication batch record discrepancies, non-conformances with managementIssued production batch records and product labels for clinical manufacturingCreate work practices for Oracle disposition checklistRecognize and solve Quality issues routinely.Train new and current specialists in quality assurance disposition processes. Support internal audit.Create forms and SOPs for new product lines.Train peers on Celabs for generating CoAs.Ability to effectively multi-taskSystems – Celdox, Oracle, Celabs, eQRMS and Compliance Wire

Lawrence Township, Nj, Us

Responsible for disposition activities for site manufactured CAR-T drug product and raw materials Perform QA shop floor activitiesEnsure manufacturing compliance with applicable procedures and batch recordsReviewed CAR-T records for PBMC Isolation, wash, cryopreservation, lentiviral transduction, cell culture maintenance, final drug product and all associated ancillary documents.Lead project to upload the executed batch records and testing documents into VeevaVault.Review manufacturing shop floor documentation.Support internal auditCreate forms and SOPs for new product lines.BLA data verification Create drug product label specifications.Issues production batch records and final Drug Product labels to manufacturing operations.

Morris Plains, New Jersey, Us

Provide oversight to operations on the shop floor, and support manufacturing operations at real timePerform routine manufacturing batch record review Support manufacturing operations and staff as needed to identify and address product quality and compliance issues as they arise. Review documentation associated with production operations. Ensuring adequate levels of documentation are acceptable and compliant to existing procedures. Initiate deviations and/or NOEsWrite, review, and approve SOPs as needed. Visually inspect and disposition raw material for production use. Develop and deliver GDP trainingHelp develop SOPs and job aids for manufacturing support teamPerform line clearance (room clearance) for production use. Completed data integrity training with Monica Cahilly (Green Mountain QA llc.)

San Antonio, Tx, Us

Compliance with GMP and SOP requirements where applicable in the facility.Perform standard solution changes throughout the processes of tissue with minimal supervision.Assist with regular RTU and Freeze-dry tissue splitting procedures. Sterilization prepping of tools used in the procedures. Train aseptic operations to new associates in class 100 cleanroom.Defat and assess the human tissue.Performing 5S-Lean auditsData entry in Oracle, R12, and SAP ERP system. Reviewed batch records at the end of each shift.Trained peers in department.

Dublin, Coolock, Ie

• Write business scenarios• Write test scripts for Validation of SAP system • Perform UAT testing of SAP system• Train the Manufacturing team to SAP/ERP system• Develop training material for the training department• Help QA investigate CAPAs and NCRs in SAP system• Data entry in SAP system

Bachelor Of Science (B.A.), Biology/Biological Sciences, General

Bachelor'S Degree, Biology, General

Associate Of Science (A.S.), Pre-Medicine/Pre-Medical Studies

High School Diploma, High School/Secondary Diplomas And Certificates