Jay Bolden
Senior Director – Quality – Biologist of Eli Lilly & CompanyMr. Jay Bolden is a Senior Director in the Eli Lilly and Company Global Quality Laboratories. He is an internal bacterial endotoxins subject matter expert and leads a team with global QC oversight for developing, validating, transferring, and troubleshooting endotoxin, microbiology, QPCR and ELISA methodologies. Jay holds a B.S. in Biology and an Environmental Studies certificate from Indiana University. Jay has over 23 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership. Jay is a member of the United States Pharmacopoeia Microbiology Expert Committee.
Robyn Hofer
Operations Manager at CBE Pure SolutionsRobyn has almost 20 years extensive pharmaceutical experience within the QC Laboratory. Robyn has a proven ability to ensure compendial and regulatory compliance and establish quality systems. Robyn has experience in co-hosting and participating in TGA, FDA and ANVISA regulatory inspections and customer audits and is yellow belt certified. Additionally, Robyn is a skilled change agent in challenging, influencing and supporting departmental practices, policies, systems, attitudes, and structures.