(Glenview, IL) July 9, 2013 – BioTechLogic, Inc., a biopharmaceutical manufacturing and CMC consulting firm, today announced the addition of Alex Gibb to its growing team of technical experts and consultants. As Manager, Analytical Services, Gibb will support clients by developing analytical method validation and qualification strategies, preparing method validation and qualification protocols and reports, reviewing internal reports to identify gaps in ICH and regulatory compliance, providing guidance on method requirements and capabilities, providing consultancy on technology transfer, managing third party CRO and CMO testing laboratories, preparing CMC regulatory documentation for IND/BLA/MAA submissions, and performing QC and laboratory audits. Alex was most recently at Novartis Vaccines and Diagnostics in their Analytical Services group, the world’s fifth-largest vaccines manufacturer and the second-largest supplier of influenza vaccines in the United States.
“We’re experiencing a critical time of company growth, and Alex enhances our team’s ability to continue to provide a tremendous breadth of analytical expertise and knowledge,” said Patrick Giljum, Head of Operations, and co-founding Partner of BioTechLogic.
Alex brings over thirteen years experience in the biopharmaceutical industry. In addition to Novartis, he has previously held various positions with Amgen, Sirna Therapeutics and Eltron Research, where he provided analytical technical support; and developed, transferred, qualified and validated methods including UV, HPLC, SDS-PAGE, and MS based methods. Alex has a BSc (Hons) in Ecology with Biology from the University of East Angila, Norwich, United Kingdom.
BioTechLogic has developed proven methodologies and approaches for providing reliable and dependable services to clients in the pharmaceutical industry. For more information about BioTechLogic, visit www.biotechlogic.com or call 847-730-3475.
About BioTechLogic
BioTechLogic, Inc., is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization’s technical, manufacturing, analytical, and regulatory resources. The firm offers expertise in process development, BioAnalytical services, process validation, project management, quality assurance, regulatory submissions and Pre-Approval Inspection (PAI) readiness. BioTechLogic’s quality by design (QbD) approach enables the company to effectively provide product development support, including: development reports, design of experiments, technology implementation, critical process parameter evaluation, technology transfer and scale-up, and on-site third party contract manufacturing support.
