Joaquin Iglesias

Experience

1. Sr Manager - Manufacturing

   Kincell Bio

   Apr 2023 — Present · Gainesville, FL, US

   Lead a team of 6 members to help established manufacturing, safety and training programs for Kincell Bio. Helped established the following programs: Personnel, Material, Waste, and Sample Flows for Manufacturing Department Qualification programs for Gowning, Aseptic Technique, and Visual InspectionSafety Programs: Emergency Response and Action Plan; Incident Reporting, Blood Pathogen and Exposure Control Plan, and othersPerformed and authored the following risk assessments: Microbial, Cross-Contamination, and Adventitious agents. Establish Training Program for Manufacturing ProcessesProvide Training on Cell Processing, Cell Selection, Cell Activation, Cell Expansion, Cell Harvest, and Final Fill / Cryogenic Storage Drive High-performing culture: Implement Good Catch Programs to promote safety awareness and actionsAudit training programs (laboratory techniques, environmental monitoring, etc) to comply with regulations and best practices.Perform gembas to ensure manufacturing processes are optimal, efficient, and safe. Review and provide guidance on raw materials, consumables, and ancillary materials to meet specification. Provide inventory control management of these materials Lead Day-to-Day Technology Transfers: Review Process Development protocols, reports, and tech transfer packet and perform facility fit and compliance reviews into manufacturing areasBuild List of Materials (LOM)/ Bill of Materials, Sample Plans, Equipment List and Process Flow Diagrams to ensure tech transfer success.Lead cross-functional organizational teams in technology transfers from the sending unit (both internal and external) to the Gainesville, FL based clinical-scale manufacturing facilities. Provide leadership to the project team in risk management, including assessment, communication and mitigation of risksAble to successfully transfer a project through Process Qualification and into clinical manufacturing

Education

• Babson F.W. Olin Graduate School of Business

  Certification

  2019 — 2020

• Babson F.W. Olin Graduate School of Business

  Master of Business Administration - MBA

  2020 — 2024

• The University of Texas at Austin

  Chemistry

  2003 — 2006

Skills

• Standard Operating Procedure (Sop)
• Microsoft Office
• Quality Assurance
• Chemistry
• Biotechnology
• Cross-Functional Team Leadership
• Pharmaceutical Industry
• Sop
• Fda
• Analytical Chemistry
• Quality System
• Validation
• Change Management
• Gmp
• Microsoft Excel