Laureano Camacho. Molecular Cell Biology
Director Development Quality @Emergent BioSolutions
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WORK HISTORY
Director Development Quality @Emergent BioSolutions
San Diego, CA, US
Key responsibilities, achievements and goals. • Lead all; Quality Assurance, GxP Compliance, GxP Training and Validation activities including Document Control and Data Integrity. • Have oversight of quality and compliance aspects for clinical trials for vaccines development with the labs. • GCLP oversight of Clinical Immunology Laboratory. • Ensure the assessment of key quality outputs such as protocol deviations, product complaints, and audits. Oversight of the clinical batch disposition. • Provide leadership and strategic direction to the San Diego Quality site(s): Nancy Ridge and Sorrento Valley sites.• Participate and provide guidance on Development of Phase Appropriate process for San Diego sites. • Ensuring the proper interface of the quality function to product development, manufacturing, engineering/maintenance, laboratories, and other areas as required.• Builds strong relationships with internal and external customers-to build, enhance and ensure quality awareness. • Collaborates with all departments to ensure that quality standards and GxP (GCO, GLP, GMP) compliance are met and maintained, including Document Control, Data Integrity (ALCOA ++), Quality Agreements, contracts, Investigations, CAPA analysis and Deviations. • Develops, harmonize with global teams and monitors appropriate metrics to track quality and process improvements. • Develops the required sites processes and competencies to ensure that quality standards are implemented in accordance with corporate goals.• Supports the QMS transformation across the site and all Quality Management Systems at the sites.• Lead, host, support, prepare teams for internal and supplier audits.
EDUCATION
Universidad Pedagógica Nacional
Bachelor of Science - BS, Biology
University of Wisconsin-La Crosse
Master of Science - MS, Cellular & Molecular Biology
ABOUT LAUREANO CAMACHO. MOLECULAR CELL BIOLOGY
In-depth experience supporting QA/RA and Operations teams to achieve goals on time or sooner in a manufacturing environment. Results oriented focused on high standards, work ethic and safety. Dedicated to constant innovation to face the challenges of improving people’s lives in constant changing R&D, commercial and manufacturing markets while using Six Sigma Green Belt, Lean and Scrum Master - Lean tools.Competencies:Extensive knowledge of global biopharmaceutical, biotech, CDMO, CMO, clinical industry and regulatory compliance environment, ISO graded clean rooms.Strong GMP-GxP-GCP-GLP QA/RA/QC in cooperation with operations and business environments at HQ level.Comfortable leading regular Management Review meetings with all Senior Leadership Team including Quality Leadership Teams.Experienced and skilled with FDA, EMA, CLIA, EHS, GMP, ISO, ANSI, USPs, CFR, Monographs, ISO, ICH Data Integrity (ALCOA ++), application of Phase-Appropriate (TR-56), SCAR (Supplier Corrective Action Request) processes management, Chemistry Manufacturing and Controls (CMC) and other.Direct and indirect experience hosting FDA and all regulatory inspections with great outcomes.Member of Site Leadership Teams (SLT) and Quality Leadership Teams (QLT).Managerial experience with direct and indirect reports in diverse environments. Working with Director of Quality and Regulatory Affairs, Senior Director of Quality, Directors of Operations and Regional Managers. Budget creation and budget management experience.Experience in 5S, Kaizen, and other Lean tools; writing, training and implementation of SOP and validation protocols. Change Management. Project Manager and Director. Comfortable handling risk and uncertainty with business acumen-Technical CompetenciesSkilled on: MS Office suite, Visio, Cali Mgr (Blue Mountain), Minitab, Yokogawa, testo Systems, Reg Asset Mgr (RAM), C3ME/JDE, Ariba, Coupa, PeopleSoft, Lotus Notes, Outlook, Veeva, Workday, Tutela, TrackWise, AuditUtopia® software system and other. Experience with Technical writing for Pharma, Biotech and Medical Devices.
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