Jesse Semf Email & Phone Number

New York, NY, US

Foster City, CA, US

Quality Risk Management, Global Quality Systems & Compliance

Foster City, CA, US

Managing projects and providing support to Biologics QA, with a focus on continuous improvement and operational excellence.

Foster City, CA, US

Basel, Baselstadt, CH

- Support Supplier Quality functions for new and existing vendors, suppliers, service providers and contractors for the Kymriah platform- Supplier and material qualification- Support audits, both internal and external- Supports investigations from a Supplier Quality perspective

Basel, Baselstadt, CH

Managing compliance activities within the Supply Chain group for the CAR-T therapy Kymriah, including deviations, CAPAs, and change control.

Basel, Baselstadt, CH

• Initiate, investigate, maintain, and close deviations for GMP pharmaceutical manufacturing facility
• Work closely with quality assurance, maintenance, metrology, manufacturing management and technicians to formerly document and move deviations through the system of approval
• Conduct root cause analysis and perform corrective actions to be proactive and prevent future deviations
• Member of cross-functional team performing process improvements related to compliance activities (deviations, CAPAs) to improve efficiency and maintain a state of control
• Promoted within role to Senior Compliance Specialist (formerly Compliance Investigator) in September, 2017

Paris, France, FR

• Principal Investigator of DeviationsMay 2014 – November 2015sanofi pasteur – Swiftwater, PA
• Initiate, investigate, maintain, and close deviations for GMP pharmaceutical manufacturing facility
• Work closely with quality assurance, maintenance, metrology, manufacturing management and technicians to formerly document and move deviations through the system of approval
• Conduct root cause analysis and perform corrective actions to be proactive and prevent future deviations

Paris, France, FR

• Selected by senior management to be a member on the Adapt team, monoclonal antibodies process development
• Train on cell culture process, from shake flask through bioreactor
• Focus on 50L & 200L bioreactors and wave bioreactor, bag installation, initial setup and final break down of disposables, HMI and software interface set up and ongoing performance, maintenance of all hardware and.
• Work with Engineering and Automation on gas strategy for large scale bioreactor skids, based on development data
• Author/edit/review batch records and SWIs for new process
• Transition and scale up development runs to fit process in large scale manufacturing facility

Paris, France, FR

• Key member of a cross functional team that includes batch release, materials management and IP, regulatory, quality and sterility assurance, information solutions, various management teams; as well as software vendor.
• Support outsourcing of materials materials
• Provide detailed process knowledge as the SME to the MES project team
• Support the change control activities surrounding:o Getting materials approved for use in manufacturingo Outsourcing of materialso Process streamliningo MES implementation
• Design and configuration of the eBR using XFP MES software which uses both a visual workflow tool as well as logic based coding for decision paths, checking of parameters, trace of materials and equipment, etc.
• Assist with systems integration (SAP, Documentum, scales and meters)

Paris, France, FR

• Room leader/senior technician of the buffer preparation room in the Biological Services Area
• Worked closely with a team technicians to compound media and reagents according to a production schedule used to supply site wide production demands
• Performed daily tasks in accordance with cGMP regulations, Standard Operating Procedures and Standard Work Instructions to ensure product specifications were met while working in a safe and efficient manner
• Followed departmental production schedule and provided the necessary coverage and support to meet the site wide demands
• Grade A sterile conditions experience in performing critical filtrations while maintaining proper aseptic technique to ensure a high quality product was manufactured
• Maintained high proficiency in documentation in Batch Production Records and work area logbooks.

Bachelor Of Science (B.S.), Business Management

Business Management