Shyamosree Bhattacharya Mc Cain, Ph.D.
About Shyamosree Bhattacharya Mc Cain, Ph.D.
Shyamosree Bhattacharya Mc Cain, Ph.D., is the Director of Quality Control at Alpine Immune Sciences, Inc., where she has worked since 2022. She has organized and led various expert panels and workshops, and possesses extensive knowledge of regulatory guidelines and compliance in the pharmaceutical industry.
Work at Alpine Immune Sciences
Shyamosree Bhattacharya Mc Cain, Ph.D., has been serving as the Director of Quality Control at Alpine Immune Sciences, Inc. since 2022. In this role, she oversees quality control processes and ensures compliance with regulatory standards. Her responsibilities include leading initiatives related to the analytical characterization of biologics and maintaining cGMP compliance. She plays a crucial role in the company's quality assurance framework, contributing to the development and oversight of quality systems.
Education and Expertise
Shyamosree Bhattacharya Mc Cain holds a Ph.D. and possesses extensive knowledge in regulatory guidelines, including 21 CFR 211, FDA, ICH, and USP standards. She is a USP certified Trainer, which underscores her expertise in quality control and regulatory compliance. Additionally, she has obtained certificates in Operational Excellence, Capital Project, and Strategic Thinking, enhancing her qualifications in managing quality processes and projects.
Background
Shyamosree Bhattacharya Mc Cain has a strong background in quality control and regulatory compliance within the pharmaceutical and biotechnology sectors. She has organized and led various expert panel meetings, including the Insulin Expert Panel, Viral Vaccine Panel, and Peptide Mapping Panel. Her experience includes conducting FDA audits and site inspections, which demonstrates her familiarity with regulatory environments and compliance requirements.
Achievements
In 2020, Shyamosree Bhattacharya Mc Cain led the USP Osmolarity Workshop, showcasing her leadership in advancing industry standards. As a subject matter expert in cGMP compliance and analytical characterization of biologics, she has contributed significantly to the field. Her involvement in expert panels and workshops highlights her commitment to fostering collaboration and knowledge sharing within the industry.