Sayak Ghosh

About Sayak Ghosh

Biopharma professional with more than 6 years of experience in biosimilars, vaccines, and…

Experience

1. Research Associate

   Dr. Reddy's Laboratories

   Jun 2022 — Present · Hyderabad, IN

   Developed, managed and validated immunoassays for PK and immunogenicity (ADA, NAb) using sandwich and bridging ELISA and ECL (MSD) platforms in a GCLP-compliant lab, supporting clinical trials and regulatory submissions.•Experienced in eLNB, LIMS, QMS, DMS, SAAS-JMP for data processing, data transfer, statistical analysis, and data visualization.•Handled QMS tools, change management, CAPA investigations, deviations and incidents, out of calibration, out of specification, quality risk assessments, GxP impact assessments, and equipment qualification, impact assessment.•Implemented Laboratory Information Management System (LIMS) for Bioanalysis including Sample Management, Inventory, Method Validation modules for QMS advancement•Implemented LSRD module in DocHub to ensure data integrity of study and molecule level documents.•Managed GCLP compliant facility establishment project for insourcing and closely worked with QA to address quality queries to ensure compliance.•Prepared and reviewed laboratory SOPs, reports, risk register, URS, job safety analysis, PQ script, validation plans, qualification documents, CSV protocols and scripts.•Worked in collaboration with CRA, CDM, Clinical Site Engagement Teams, QA, IT and outsourcing Clinical Operation team.•Managed and oversaw method transfer, validation, Sample receipt, storage, analysis, archival through regular communication with external service providers (CROs and central labs) ensuring Sample Integrity, Chain of Custody, regulatory compliance, addressing ethical considerations.•Independently managed inventory, vendor qualification, procurement and shipment for assigned projects.•Ensured data integrity by following ALCOA++ practice and compliance as per regulatory requirements (FDA, EMA, MHRA, CDSCO, ICH- GCP, M10 GLP, 21CFR Part 11) and as a part of audit readiness.•Volunteered as a member of DEI Local Diversity Council, First-Aider, Safety Star-Cap, PwD Employee Resource Group.