Anurag Vinit Wadhavkar

• Led and managed Chemistry and Manufacturing Controls (CMC) projects to support the development of Immuno-Oncology and Cardiovascular therapies, ensuring alignment with regulatory requirements and submission timelines.
• Authored IND amendment sections for Drug-Product Release Assay Qualifications, contributing to successful regulatory submissions in compliance with FDA guidelines.
• Designed, developed, and validated Analytical Potency Assays as per ICH guidelines, generating high-quality data and reports to support regulatory filings.
• Directed technology transfer projects to CROs for GMP-grade component testing, including AAVs, T-cells, and Lipid Nanoparticles, ensuring consistency with regulatory expectations.
• Collaborated across departments (Research, Process Development, Quality Control, and Quality Assurance, Regulatory) to establish regulatory-compliant manufacturing processes, stability studies, and release assays.
• Partnered with Quality teams to maintain compliance with FDA, ICH, and GMP standards, contributing to the successful qualification of CAR-T drug product release assays.
• Supported regulatory filing preparation by developing technical documents and ensuring accuracy and clarity in compliance with global standards.

• Spearheaded Mechanism of Action (MoA) studies for lead Drug Candidate targeting Alzheimer’s Disease, utilizing advanced analytical techniques to generate critical data for preclinical regulatory submissions.
• Authored and presented technical findings to cross-functional teams, aligning study outcomes with therapeutic development goals.
• Reviewed and integrated findings from scientific literature to design robust experiments, enhancing the quality of data submitted for regulatory consideration.
• Designed and Executed critical efficacy studies for the lead Alzheimer’s Drug Candidate contributing to the preclinical regulatory submissions.

• Supported antibody-based therapy program, contributing to key CMC documentations.
• Performed and documented molecular biology techniques with precise recordkeeping to ensure data integrity for regulatory compliance.
• Produced and validated lentiviral vectors for intracellular signaling assays, establishing reproducible workflows in alignment with preclinical study protocols.

• Worked on a chaperone (NACHO/TMEM35) necessary for the assembly and surface expression of neuronal type nicotinic acetylcholine receptors.

Studied the activation of the JAK-STAT pathway through IL-6 receptors using a cell-based reporter assay.

Executed immunohistochemistry, immunocytochemistry, and Western blots to examine TMEM35 expression in HEK cells.