Juan Figueroa

About Juan Figueroa

Chemist with Regulatory and Lean Six Sigma training. Over 18 years of experience in Biotech, Pharmaceutical and IVD fields reflecting experience in Process Development and Transfer, Technical Support, Validation, Manufacturing, QC and Project Management. Experienced two manufacturing plant start-ups and worked in the Re-Validation and Re-Engineering of a company under a Consent Decree employing Lean Six Sigma tools. Over 14 years of Management experience leading teams through challenging scenarios such as plant start-ups, organizational integrations, a Consent Decree and multiple Product Development and Commercialization efforts. Working knowledge of ISO Standard 13485 and Title 21 CFRs 210, 211, 601.2, 807, 814 and 820.

Experience

1. Sr Director - Operations, Process Transfer

   Hologic, Inc.

   Nov 2021 — Present · San Diego County, CA, US

   Lead team in charge of transferring robust manufacturing, testing and business processes into Operations in support of Product Development. This includes manufacturing and testing of all lifecycle stages of our high-quality products, from early feasibility through clinical lots of most assay components, sub-assemblies and active ingredients. • Partner with corporate supply chain to drive supplier selection and performance measures into early new product development (NPD).Lead team that manufactures and tests high quality active ingredients, sub-assemblies and small scale reagents for Commercial use as well as Technical Support of certain Commercial manufacturing and business processes. • Drive and maintain processes for assessing production processes for cost, efficiency, and quality in addition to loading and managing all projects or initiatives aimed at improving those production processes, including, but not limited to, scale changes, automation, error-proofing, documentation improvements, and addition or removal of in-process tests.• Together with other senior Operations leaders drives culture of respect, integrity, accountability with a focus on continuous improvement and empowerment of Operations employees at all levels. • Process integration for new acquisitions in diagnostics, move of production to new sites both within the facility and between facilities.• Identifies and eliminates or mitigates major COPQ (cost of poor quality) processes. Reduces defects with the goal of becoming defect-free. • Continuously improves company’s organizational capabilities to achieve process quality as part of project execution, including an awareness of the need to “do it right the first time.” • Supports project teams in process quality activities by educating, coaching and mentoring others on process improvement philosophy, tools and application.

Education

• RAPS (Regulatory Affairs Professionals Society)

  Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals, Regulatory Affairs

  2012 — 2013

• Villanova University

  Master Certificate in Lean Six Sigma, Lean Six Sigma

  2013 — 2014

• University of Puerto Rico

  Bachelor in Science, Chemistry

  1994 — 1999

Skills

• Validation
• Oracle E-Business Suite
• Operations Management
• Six Sigma
• Product Launch
• Gxp
• Aseptic Processing
• Capa
• V&V
• Process Simulation
• Sap
• Oracle Agile Plm
• Change Management
• Product Development
• Ivd
• Trackwise
• Leadership
• Commercialization
• Resource Management
• Manufacturing
• Strategy
• Regulatory Affairs
• Purification
• Process Improvement
• Project Planning
• Cleaning Validation
• Change Control
• Microbiology
• Fermentation
• Management
• Product Management
• Biotechnology
• Cross-Functional Team Leadership
• Performance Improvement
• Biopharmaceuticals
• Iso
• Sop
• Fda
• 21 Cfr Part 11
• Project Management