Jay Bolden (Senior Director – Quality – Biologist of Eli Lilly & Company)

Jay Bolden

Senior Director – Quality – Biologist of Eli Lilly & Company

Mr. 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 Solutions)

Robyn Hofer

Operations Manager at CBE Pure Solutions

Robyn 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.