Lucas Hernandez Colon

Lucas Hernandez Colon

Sr. Director Corporate Manufacturing Compliance

Baxter International

Pharmaceutical Quality, Validation and Scientific Professional with over25 years of regulated industry experience in the quality, validation,technical services, manufacturing and process development environments (Parenteral Manufacturing, Solid Dosage and Biotechnology DS). Fully knowledgeable of regulatory matters: EPA, OSHA, FDA, ISO. FDA
Consent Decree experience and Plant Approval FDA and EMEA Audits. Dedicated, focused, and quality-oriented professional. Highly respected for consistently demonstrating hands-on process while applying best practices to critical manufacturing initiatives and product launches.

Expertise
• Strong experience in Parenteral Plant Remediation Plans managing and supervising activities for the implementation. Regulatory inspection support and response writing.
• Strengths in Biotechnology Plant Start Up in Drug Substance of
Biologics-Biosimilars • Expert in Documentation, APR, Training & Development, Validations (Equipment, process, cleaning), Process Development.
• Expertise in Quality Systems (Batch Record, Investigations, Change Control and Complaints Invest.)
• Pre-Approval Inspection preparation and support. Direct interaction with FDA, MHRA, INVIMA auditors.
• Manager for the Remediation of Quality/Manufacturing/
DS/Packaging/ Utilities/ Facilities/Materials and Production
Planning.
• Expert on Injectables Visual Inspection Program Creation including, inspection technique design and implementation, inspectors training and certification, Defect categorization and classification SOP Generation, Process Flow, Units Handling improvement.
• Plant Manager – Coordinate and oversees plant activities through the planning process with departmental managers ensuring the effective allocation of resources and full utilization of assets to produce expected results in production output, product quality and complying with shipping schedule.

Education
• Ph.D., Env. Sci. Organic Chemistry, Univ. of Turabo, Puerto Rico,
• M.S., Biochemistry, Univ. of Puerto Rico, Dec. 2008
• B.S., Chemistry, Univ. of Puerto Rico, May 2000