Stephen Lavigne Email & Phone Number

Washington, Dc, Us

Gaithersburg, Maryland, Us

Somerset, Nj, Us

Catalent Gene & Cell Therapy Harmans, MDSenior Director of Operations September 2020Responsibilities include oversight commercial and clinical manufacturing operations of mammalian cell culture and purification of gene therapeutic proteins and vaccines. Oversight of Manufacturing Technical Operations and Drug Product Manufacture.• Built a Team of Directors, Managers, and associates of > 350 Staff• Start up 9 Manufacturing Suites• FDA approval of first CDMO gene therapy product• First FDA inspection during COVID Pandemic• EMEA and Japanese approval of Viral Vector Vaccine • Manufacturing lead for design of new Building which includes 8 additional suites.Catalent Gene & Cell Therapy Harmans, MDSenior Director Downstream Manufacturing August 2019 to September 2020Responsibilities include oversight commercial and clinical manufacturing Downstream Operations of mammalian cell cultures.

Lawrence Township, Nj, Us

Responsibilities include leading a group of scientists and engineers in design, execution and analysis of bio-separations techniques include chromatography, centrifugation, ultrafiltration, and filtration experiments.• Technology Transfer• Health Authority Responses, IND/BLA Support• Commercial Process Support

Lawrence Township, Nj, Us

Responsibilities include leading commercial manufacturing of biologic drug substance operations, areas of oversite include dispensing, inoculum scale up, cell banking, cell culture and purification. Staffing consists of 120 personnel (managers, supervisors and operators) in a 24/7, 365 day operation.• Key member of management during the transition to an Integrated Cross Functional team. (ICT) The ICT integrates manufacturing, maintenance, metrology, and quality field into a 4 cohesive teams cover 24/7 operations• Lead for all regulatory inspections• Budget and Resource Planning

Lawrence Township, Nj, Us

Bristol-Myers Squibb Syracuse, NYUpstream Group Leader, Manufacturing March 2015-presentCell Culture ManagerResponsibilities include managing commercial and clinical manufacturing of mammalian Cell Culture and associated media and harvest operations. Oversight Dispensary operations which support all manufacturing areas. Oversight of Cell Banking operations, which supports clinical and commercial Cell Banks for BMS network. Staffing consists of 57 operators and supervisors in a 24/7, 365 day operation.• Lead integration of Cell Banking, Inoculum, Cell Culture and Dispensary groups into Upstream ManufacturingBristol-Myers Squibb Syracuse, NYCell Culture Manager, Manufacturing August 2011-March 2015Responsibilities include managing commercial and clinical manufacturing of mammalian Cell Culture and associated media and harvest operations. Staffing consists of 38 operators and supervisors in a 24/7, 365 day operation.• Op Ex Yellow Belt Certified• Green Belt Certification in Progress• Implemented Visual Management• Works interdepartmentally to ensure production schedule is maintained.• Developed Staffing models based on various products and cadences• Detailed analysis of pay structure • Developed Departmental Budgets• Lead and Drove Inspection Readiness (5S Programs)• Representative for BMS for BPOG Contamination Control• Lead Various Regulatory Inspectors through facility during inspections• Participated in many cross functional teams • Determined Validation strategy to level load production schedule by increasing hold times• Changed Culture from a Punitive Culture to Just Culture• Held support groups responsible for their own work• Devised Overtime Policy, and decreased total amount of OT worked by 50%• Leads Cross functional network wide Manufacturing-Development Interface Team

Lawrence Township, Nj, Us

Responsibilities include Purification, Solution Preparation and Technical Transfer of bacterial and mammalian downstream processes in the Pilot Facility. Staffing consists of six direct. Responsibilities include scheduling, technology transfers, new technology evaluation and resource allocation in a multi-product pilot scale manufacturing facility. •Works interdepartmentally to ensure production schedule is maintained.•Works with Process Development and Manufacturing to ensure requirements of scales studies are incorporated as designed into the Pilot Plant Lots•Developed new report format, which decreased report length by 50%, while still delivering critical data to the end user. •Leads Manufacturing Group Safety Committee•Project Team Member on multiple biological process transfer and scale ups•Designed and implemented new disposable technologies in the Pilot Plant.

Princeton, Nj, Us

Responsibilities include Purification, Solution Preparation and Aseptic Filling Departments in the Clinical Manufacturing Group. Staffing has consisted of three direct reports and total staff of up to 18 employees. Responsibilities include scheduling, technology transfers, budgeting, and resource allocation in a multi-product clinical manufacturing facility. Oversight of Purification and Aseptic Filling for Clinical Supply MaterialLead Intra-departmental team for Human Error Reduction using Talisco principalsImplemented procedures for identification, and procurement of critical raw materials to secure supply chain.Works inter and intradepartmental to ensure production schedule is maintained.Long term scheduling and planning (> 1 year)Plans and administers facility shutdowns and repairs.Designs of Future Production Facility.Clinical Manufacturing lead on several Quality Policies which includes the Production Systems and the Packaging and Labeling systems.Authors Non-Conformance Reports, CAPAs, Batch Records, SOPs, and other GMP documentation.

Supervise six operators in a multi-product cGMP contract manufacturing facility. Responsible for the generation of production schedules, batch records, SOPs, and performing lot reviews. Lead role in technology transfers from process development to manufacturing.Interview and hire new employees.Coordinate with other departments to ensure required support for critical process monitoring, buffer preparation, validation, product changeover, maintenance, etc., is provided.Supervision of operators includes scheduling of shift work for operating 24 hours/day, 7 days/week.Work with the process development group for technology transfers of new products. Lead role in SOP and batch record generation and review.Responsible for ensuring that all equipment, materials, SOPs, and batch records for new processes are approved, validated and ready for operations.

Reviewed process design drawings for operability and compliance.Lead role in approving isometrics and monitoring construction activities.Reviewed P&IDs and generated As-built drawings of process areas.Lead role in the generation of Fisher-Rosemount Functional Requirement Specifications.Daily activities in the purification manufacturing area included operations of chromatography, ultra-filtration and CIP skids.Operated and packed various types of chromatography columns up to 80 cm.Worked with affinity, ion exchange, and size exclusion resins.