Basak Clements
Company: No Company
Job title: Independent Raw Materials Expert
Bio:
Basak Clements, PhD, is the Founder and Senior Advisor at biomatria, a scientific consultancy specializing in materials science and management for the biopharmaceutical and advanced therapy industries. With over 15 years of experience, Basak is a seasoned biopharmaceutical development leader, driving innovation in cell and gene therapy (CGT), biologics manufacturing, and materials science. As a Senior Advisor at biomatria, she provides strategic consulting to biopharmaceutical companies, research institutions, suppliers and CDMOs, with a focus on raw, starting and single-use material management for biologics and advanced therapies.
Previously, Basak served as Global Head/Senior Director of Cell and Gene Therapy Materials Science at Roche/Genentech, where she implemented material sciences strategies and a risk-based material control framework for the multi-billion-dollar CGT pipeline. She led global teams of scientists and engineers across multiple sites and was a member of the Senior Leadership Team, influencing strategic decisions for Roche’s CGT Process Development and Manufacturing organization.
Before joining Roche/Genentech, Basak held Process Development and Supply Chain roles in Materials Science and Material Management at Johnson & Johnson (Malvern, PA) and Amgen (Thousand Oaks, CA). Earlier in her career, she worked in academia as a Postdoctoral Researcher and Fellow at Rutgers University and the New Jersey Center for Biomaterials (Piscataway, NJ). Basak holds a BSc and MSc in Chemical Engineering from METU (Turkey) and an interdisciplinary PhD in Chemical Engineering, Pharmacy & Pharmaceutical Sciences from the University of Alberta (Canada).
Seminars:
Chair’s Opening Remarks 9:00 am
day: Conference Day One
Chair’s Closing Remarks 4:30 pm
day: Conference Day One
Think Tank: Streamlining Supplier & Material Selection & Qualification – Opportunities for Collaboration & Harmonization 2:45 pm
Review of RFI/RFP documents and information requests from suppliers for initial selection of material/supplier Supplier qualification practices and opportunities to streamline – paper audits, remote audits, on-site audits, 3rd party audits, certifications Material qualification practices and opportunities to streamline – fit-for-purpose questionnaires and risk assessmentsRead more
day: Conference Day Two