Subject: GMP

J. Jeff Schwegman, Ph.D.

J. Jeff Schwegman, Ph.D. is the founder and chief executive officer of AB BioTechnologies, where he manages the day to day operations of the company. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington, Indiana, where he gained experience in analytical, formulation, and process… Continue reading J. Jeff Schwegman, Ph.D.

Irwin Silverstein, Ph.D.

Irwin Silverstein has been a consultant to the pharmaceutical industry since 2000. His career included 17 years as the head of corporate quality for ISP, a specialty chemical manufacturer that produced excipients and active pharmaceutical ingredients. Since leaving ISP, he has worked as a consultant. He has been a subcontractor to a consulting firm hired… Continue reading Irwin Silverstein, Ph.D.

David E. Wiggins

David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation, and method transfer. Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for method optimization, method validation,… Continue reading David E. Wiggins

John O’Neill

John O’Neill earned his Bachelor’s degree in Pharmaceutical Sciences from Columbia University and a Master’s in Health Systems Management from Union University. His career of 43 years has taken him from Registered Pharmacist to-Liquids and Semi-solids Formulator at Sterling Winthrop, QC Manager at Sanofi-Aventis, Medical Device Quality Steward at Boston Scientific, Independent Consultant, Principal Stability… Continue reading John O’Neill

Karl F. Popp, R. Ph.D.

Karl Popp founded KPopp Consulting, LLC in 2010 as a consulting firm providing services to the pharmaceutical, cosmetic, and allied industries. He is also a practicing retail pharmacist. During his career, he has been responsible for the development of products that have generated over $2 billion in sales. From 1989 to 2008, he was associated… Continue reading Karl F. Popp, R. Ph.D.

Barry Friedman Ph.D.

Barry A. Friedman, Ph.D. is a Senior Consultant in the biotechnology, regulatory compliance, microbiology, and aseptic processing arenas. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director of Quality Control, he managed a multi-shift… Continue reading Barry Friedman Ph.D.

Joseph A. Albanese, Ph.D.

Joe Albanese is Owner and Managing Director of Albanese Consulting LLC, which he formed after more than 29 years of experience in the pharmaceutical industry. He recently retired from Janssen Pharmaceuticals (part of Johnson & Johnson), where he held positions in R&D, Supply Chain, and Quality in both Small Molecule and Biotherapeutics development and manufacturing. As… 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 of 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 has enabled her to manage the in-house and outsourced scientific activities at Peptomyc since 2014. Marie-Eve… Continue reading Dr. Marie-Eve Beaulieu

Ginette Collazo, Ph.D.

Ginette Collazo, Ph.D. is an Industrial-Organizational Psychologist with 20 years of experience who 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 industries. Ten years ago, Dr. Collazo established Human Error… Continue reading Ginette Collazo, Ph.D.