Tanya Shah

Scientist with 5+ years of experience in pharmacology assay development supporting cell and gene therapy programs across early discovery and IND-enabling phases. Demonstrated expertise in immunoassay development (ELISA, Luminex, MSD multiplex), ligand binding assays (Octet BLI), flow cytometry, and functional cell-based PD assays. Skilled at designing, optimizing, and qualifying bioanalytical methods, authoring regulatory documentation, and leading cross-functional work streams.

Proven ability to mentor junior scientists, operate with a high degree of scientific independence, and deliver high-quality data to support program advancement and candidate selection.

Scientist - Genezen - Indianapolis, IN

(2025-09 - 2026-04)

Contributed to an 8-member Analytical Development team delivering high-quality bioanalytical results across multiple cell and gene therapy programs in a fast-paced, deadline-driven research environment.

• Ensured strict adherence to GxP standards, maintaining data integrity and regulatory compliance across all laboratory operations and documentation.
• Authored comprehensive assay qualification plans and final reports; coordinated with clients and cross-functional stakeholders to align on project milestones and deliverables.
• Developed and validated Infectious Titer Assays leveraging multi-color flow cytometry and ddPCR; designed and executed experiments with independent scientific judgment.
• Implemented Residual Host Cell DNA (qPCR) assays supporting critical quality control workflows in biologics development, with documentation suitable for IND regulatory filings.
• Implemented Vector Genome Titer assays across multiple viral platforms including Lentiviral Vectors (LVV), Retroviral Vectors (RVV), and Adeno-Associated Viruses (AAV).

Senior Associate Scientist - Vor Bio - Cambridge, MA

(2023-01 - 2025-07)

• Led development and qualification of multi-parametric flow cytometry PD assays for CAR+ cell quantification, T cell phenotyping, and viability; managed cross-functional work streams with Analytical Development and QC to ensure assay robustness and enable successful GMP implementation and tech transfer.
• Designed and optimized functional cell-based PD assays to characterize eHSC-mediated resistance to CD33-directed cytotoxic therapies; independently developed a CD33 knockout verification assay to confirm target gene disruption and support translational pharmacology readouts.
• Authored key sections of IND submissions including bioanalytical reports, SOPs, and analytical method descriptions supporting regulatory approval of cell therapy products, ensuring alignment with FDA guidelines.
• Mentored a co-op scientist in PD assay development and flow cytometry operations, enabling independent execution and contribution to assay optimization within 6 weeks.

Associate Scientist II - Vor Bio - Cambridge, MA

(2021-05 - 2022-12)

• Conducted stability studies on CAR-T drug product to characterize pharmacokinetic storage behavior and support IND submission readiness; generated data informing storage strategy and shelf-life conditions.
• Executed in-process and post-thaw analytical testing for eHSC and CAR-T programs using flow cytometry and molecular assays to evaluate cell purity, viability, donor genotype, editing efficiency, and residual impurities; data directly informed process development decisions and ensured product consistency.
• Developed and optimized custom multiplex immunoassays (Luminex, ELISA, MSD) to detect residual cytokines and Cas9 protein; enabled sensitive impurity profiling critical for IND-enabling pharmacology analytics.
• Assessed antibody–antigen binding kinetics using Octet BLI ligand binding assays to characterize affinity, specificity, and binding parameters; data informed candidate molecule selection for downstream development.

Research Associate (Co-Op) - Sanofi Genzyme - Cambridge, MA

(2020-05 - 2020-12)

• Developed and executed primary immune cell-based pharmacology assays including monocyte-derived dendritic cell (moDC) differentiation and U2OS luciferase reporter assays to evaluate CD40 agonist pharmacodynamics; leveraged flow cytometry and reporter readouts to support mechanism-of-action characterization and therapeutic candidate prioritization.
• Profiled immune-modulatory pharmacodynamics in MC38 tumor cells in response to IFN-α, IFN-β, and IFN-γ; applied multi-color flow cytometry for surface marker quantification, MSD custom multiplex for cytokine profiling, and RT-qPCR for gene expression analysis to build a comprehensive PD dataset informing combination strategy selection.
• Applied CRISPR-Cas9 gene editing via transient transfection to generate target gene knockouts in MC38 cells; confirmed editing efficiency via Genomic Cleavage Assays, validating experimental models used in downstream pharmacology studies.

Master of Science - Biotechnology - Northeastern University Boston, MA

Bachelor of Engineering - Biotechnology - University of Mumbai Mumbai, India