Amala Saju

Amala Saju is a regulatory affairs professional experienced in Chemistry, Manufacturing, and Controls (CMC) across global pharmaceutical companies, including Pfizer, Novo Nordisk, and currently, Sanofi. Her expertise lies in CMC technical writing focused on pharmaceutical manufacturing processes, quality control, and product specifications to support global regulatory submissions and compliance. She has contributed to over 100 […]
Bio Rad

James Heindl

Jim has been at the Thermo Fisher Scientific / Patheon Cincinnati site since 2000. By training he is a Chromatographer, earning his PhD in Separation Science in 1998 from the University of Cincinnati under the guidance of Dr John Dorsey. He began his career on the bench as a lead development chemist then progressed to […]
Miriam Guest

Miriam Guest is the Senior Principal Scientific Advisor of Microbial Solutions. She recently joined the organization after 20 years with AstraZeneca. In her role, she provides scientific governance and strategic direction. She has extensive experience in the pharmaceutical Industry leading contamination control strategies for drug development projects as well as supporting internal and external manufacturers […]
Meghan Provenzano

Bio coming soon
Rajasekhar Reddy Poonuru

Bio coming soon
Sana Shamim

Sana Shamim is an experienced medicinal chemist with interest in computational chemistry, nanoparticles synthesis and characterization, medicinal chemistry, metal complexes and analytical chemistry evident from her research. She has expertise in the field of organic synthesis, method development on both UV-Visible and RP HPLC and characterization instruments like FT-IR, H1NMR, Mass spectrophotometer, SEM, XRD and […]
Mayank Bhanti

Dr. Mayank Bhanti has been with USP since 2019 and holds the position of Senior Director in the Compendial Development Laboratory at USP India. He leads a team of scientists involved in the modernization of monographs for small molecules (drug substances and drug products), excipients, and food ingredients. Dr. Bhanti obtained his Ph.D. from Dr. B.R. […]
Charles Heise

Charles Heise is Associate Director in the Bioprocessing Strategy & Development group at FUJIFILM Diosynth Biotechnologies working on developing connected, integrated processes. He has over 15 years of experience in the biologics industry leading the development of cGMP processes for clinical and commercial recombinant protein manufacture and academic research collaborations. He is co-inventor of the […]
Veronika Wills

Veronika Wills, Director of Global Technical Services, Associates of Cape Cod, Inc. is a recognized global subject matter expert on endotoxin and glucan detection with 18 years in the biopharmaceutical industry. Veronika is also an expert on global and local regulatory and guidelines for implementation of traditional LAL methods as well as innovative recombinant technologies […]