Subject: QA/QC

Rachel Monsef

Rachel Monsef is a consultant to the biopharmaceutical and pharmaceutical industry for analytical and quality control. She has 19 years experience working with many types of assays for all stages of drug development. Ms. Monsef has been responsible for method development, method qualification, method validation, assay transfers, characterization work and stability studies. She has been… Continue reading Rachel Monsef

Joseph A. Albanese, Ph.D.

Joe Albanese, Owner and Managing Director of Albanese Consulting LLC, which he formed after more than 29 years experience in the pharmaceutical industry. He recently retired from Janssen Pharmaceuticals (part of Johnson and Johnson) where he held positions in R&D, Supply Chain, and Quality in both Small Molecule and Biotherapeutics development and manufacturing. As part… Continue reading Joseph A. Albanese, Ph.D.

Louis Angelucci

Louis Angelucci is a pharmaceutical professional with over 20 years’ experience in Quality Assurance, Quality Control, Regulatory Affairs, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries. He has worked for several well-known companies including Johnson & Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck. His experience has… Continue reading Louis Angelucci

Dr. Marie-Eve Beaulieu

Dr. Marie-Eve Beaulieu, is Co-founder and Chief Scientific Officer, Peptomyc S.L. Dr. Beaulieu has a strong background in R&D project management and coordinates the scientific team at Peptomyc. Her experience in biochemistry and peptide and protein structure and production enabled her to manage the in-house and outsourced scientific activities at Peptomyc since 2014. Marie-Eve developed… Continue reading Dr. Marie-Eve Beaulieu

Frank Carroll

Frank Carroll is Director of Supply Chain and Facilities for Zosano Pharma/ZP Group LLC in Fremont CA. He has over 25 years of experience in the Pharmaceutical, Device, Biologics and Biotech industries in many aspects of operations including manufacturing, purchasing, materials management, strategic alliance management, implementation of advanced project management and MRP/ERP systems and senior… Continue reading Frank Carroll

David L. Chesney

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC, Cumberland Foreside, Maine. He founded the company in 2016 following 23 years with the FDA and 21 years as Vice President of Strategic Compliance Consulting Services for a major US-based CRO. He began performing GCP inspections for the FDA as early… Continue reading David L. Chesney

Ginette Collazo, PhD

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry. Ten years ago, Dr. Collazo established… Continue reading Ginette Collazo, PhD

Danielle DeLucy, MS

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 23 years serving in numerous Quality Management Roles, such as the Director of Product… Continue reading Danielle DeLucy, MS