Subramanian Senthivinayagam Ph.D.

Researcher, Father, Cricket Enthusiast

Lansdale, 19446, Pennsylvania, US.

About

Highly accomplished biomedical scientist with a Ph.D. in Endocrinology and over two decades of experience in drug discovery and development. Proven leader in preclinical efficacy, DMPK/PK/PD bioanalytical studies, consistently delivering GLP/non-GLP compliant research. Adept at strategic project management, cross-functional team leadership, and fostering stakeholder relationships to drive scientific innovation and achieve business objectives.

Education

University of Madras

Chennai, Tamilnadu, India

Doctor of Philosophy (Ph.D.) Endocrinology

Work

Invivotek, A Member of Genesis Drug Discovery and Development (GD3) Genesis Global Group

Team Leader/Program Manager /Principal Investigator & Study Director

Hamilton, New Jersey

Sep 2021→ Sep 2024

Full time

Summary

Led comprehensive preclinical drug discovery and development programs as Principal Investigator and Study Director, overseeing bioanalytical studies, facility establishment, and regulatory compliance to drive scientific innovation and business growth.

Highlights

Spearheaded the establishment of a GLP-compliant qRT-PCR facility, including IP/OQ/PQ equipment validation for 21 CFR Part 11 compliance, significantly enhancing in-house bioanalytical capabilities and enhanced revenue by 30%.

Directed preclinical drug discovery and development programs across oncology, immunology, metabolism nd neuroscience, utilizing diverse bioanalytical platforms (ELISA, MSD, IVIS, qPCR, Flow Cytometry, LC-MS) for comprehensive drug candidate evaluation.

Designed and oversaw critical DMPK and preclinical efficacy studies for novel investigational drugs, including cell and gene therapy candidates, across multiple disease models.

Managed and mentored a team of 8-10 research scientists, overseeing in vivo and in vitro activities to ensure timely and on-budget project delivery.

Authored, reviewed, and approved over 100 study-specific SOPs and related documents, ensuring stringent adherence to GLP, USDA, and FDA regulatory guidelines.

Developed and implemented novel disease models, expanding service offerings and contributing to significant business revenue growth and client acquisition.

Led scientific negotiations and provided critical scientific/operational insights for study budgeting and timeline evaluations, optimizing resource allocation and project advancements.

Cultivated strong client relationships, serving as the primary scientific liaison and subject matter expert to analyze, interpret, and present complex data, driving continued project engagement and expansion.

Eurofins Lancaster Laboratories PSS Insourcing Solutions

Process Development Scientist

Spring House, Pennsylvania

Jun 2020→ Sep 2021

Summary

Optimized downstream process scale-up for CAR-T lentivirus purification for a key client, ensuring efficient and compliant bioprocess development.

Highlights

Optimized downstream process scale-up for CAR-T lentivirus purification for Janssen Pharmaceuticals, significantly enhancing production efficiency leading to Carvykti, (Ciltacabtagene autoleucel) BCMA CART

Executed large-scale lentivirus purification (20L and 50L cell culture suspension) using liquid chromatography (LC) and Tangential Flow Filtration (TFF), leveraging Millistak+ Pod and AKTA-ready systems for high yield.

Managed comprehensive sample logistics (storage, shipping, tracking) for outsourcing sample testing at external CROs, ensuring accurate evaluation of critical process parameters.

Authored and maintained essential documentation, including protocols, batch records, dPFDs, BOM, and PPURS, for seamless technology transfer.

Precisely recorded process data in an electronic lab notebook (BioVia), ensuring data integrity and traceability for regulatory compliance.

University of Virginia, Department of Pharmacology

Research Scientist

Charlottesville, Virginia

Jun 2014→ Dec 2019

Summary

Led and managed multiple research projects focused on therapeutic efficacy, disease mechanisms, and animal model development, while securing funding and publishing findings.

Highlights

Led research projects evaluating therapeutic efficacy of potential drug targets against immune modulators for MASH and hepatic fibrosis, advancing understanding of disease mechanisms.

Directed a key project investigating Pannexin 1's role in regulating thermogenesis, obesity, and cardiovascular functions, contributing to novel scientific insights.

Secured internal research funding by successfully writing and submitting grant proposals to UVA committees, supporting critical scientific endeavors.

Authored and published multiple original research articles in top-tier peer-reviewed journals, disseminating key scientific findings to the broader community.

Orchestrated cross-departmental collaborations (Radiology, Endocrinology, Cardiovascular Research Institute) to develop and implement innovative research techniques.

Developed novel cell-type specific animal models (Cre-loxP system) for in vivo functional evaluation, accelerating research insights and capabilities.

Mentored and trained 4 junior researchers (one summer research student, one undergraduate, two technicians) in experimental design, data interpretation, and presentation.

Michigan State University, Department of Biochemistry & Molecular Biology

Visiting Research Associate

East Lansing, Michigan

Aug 2010→ Feb 2014

Summary

Managed and executed multiple research projects focused on protein interaction, cell line development, and biomarker analysis, contributing to significant scientific discoveries.

Highlights

Developed and optimized novel fluorescence resonance energy transfer (FRET)-based analysis, elucidating protein-protein interactions between Plin2 and SNAP23.

Led projects to establish stable cell lines expressing fluorescent-tagged proteins, defining structure-function relationships related to lipid droplet targeting.

Managed a collaborative study demonstrating Plin2's direct binding and transfer of lipids to/from lipid droplets, advancing lipid metabolism research.

Designed and led studies using liver-specific Plin2 mice, demonstrating protection against high fructose and MCD-diet-induced MASH development.

Led biomarker analysis studies, monitoring hepatic functions (ALT, AST, ALP) and assessing glucose intolerance/insulin resistance (GTT, ITT) to evaluate metabolic health.

Loyola University Chicago, Department of Pharmacology

Postdoctoral Research Associate

Maywood, Illinois

Aug 2006→ May 2010

Summary

Managed and executed multiple research projects focused on cancer cell biology, including mechanism of action studies, preclinical model development, and in vivo imaging.

Highlights

Managed and executed multiple concurrent research projects focused on cancer biology, ensuring efficient progress and impactful outcomes.

Authored scientific manuscripts, leading to successful publication in peer-reviewed journals, disseminating key research findings.

Led mechanism of action studies, validating small molecules/biologics to enhance TRAIL-mediated killing in drug-resistant prostate, gastric, and ovarian tumor cells.

Validated a novel combination therapy (TRAIL + Troglitazone) as an effective in vitro tumor-killing strategy against drug-resistant prostate and cancer cells.

Established robust in vivo preclinical models for gastric and prostate cancer metastasis in SCID/immunocompromised mice, enabling advanced disease modeling.

Utilized whole animal bioluminescent imaging (BLI) for real-time visualization of metastatic tumors in live animal models, enhancing research capabilities.

Texas A&M University, Department of Integrative Biosciences

Postdoctoral Research Fellow

College Station, Texas

Apr 2005→ Oct 2005

Summary

Managed and contributed to a research project investigating the role of prostaglandins, supporting fundamental biological research.

Highlights

Managed and contributed to a research project investigating the role of prostaglandins, advancing understanding of their physiological functions.

Managed ordering and supply of consumables and equipment for laboratory research, ensuring operational efficiency.

Louisiana State University, Department of Comparative Biomedical Sciences

Postdoctoral Research Fellow

Baton Rogue, Louisiana

Aug 2004→ Apr 2005

Summary

Executed research projects investigating urokinase-type plasminogen activator receptor (uPAR) in cancer, analyzing its role in cell survival and proliferation.

Highlights

Managed and executed a research project investigating uPAR's role in cancer cell survival and proliferation, contributing to cancer biology insights.

Demonstrated that cancer cells with varying proliferative capacities exhibit differential uPAR expressions, identifying a key cellular characteristic.

Analyzed the impact of RNAi-mediated uPAR knockdown on prostate cancer cell proliferation, providing insights into potential therapeutic targets.

University of Iowa, Department of Molecular Physiology and Biophysics

Postdoctoral Research Fellow

Iowa City, Iowa

Aug 2002→ Jul 2004

Summary

Investigated oligomerization of reproductive hormones and engineered novel plasmid constructs for G-protein coupled receptor studies.

Highlights

Investigated the oligomerization of reproductive hormones (FSH, LH), advancing understanding of their functional mechanisms.

Engineered novel tricistronic plasmid constructs for stable expression of differentially tagged receptors, verifying GPCR dimerization via co-immunoprecipitation.

Conducted radioimmunoassays to quantify cAMP production in response to chimeric receptor ligand stimulation, validating receptor function.

University of Madras, Institute for Basic Medical Sciences

Doctoral Research Fellow

Jan 1995→ Jan 2002

Summary

Conducted extensive research on reproductive toxicology of heavy metal pollutants, optimized bioanalytical methods, and authored scientific publications.

Highlights

Investigated reproductive toxicity of the environmental heavy metal pollutant, chromium, using rodent, primate models, and clinical samples.

Optimized bioanalytical methods for enzymatic and non-enzymatic antioxidants in primate tissues, improving analytical efficiency.

Authored questionnaires and consent forms for ethical collection of samples from workers in the tanning industry.

Analyzed and presented research data at national scientific meetings, contributing to scientific discourse.

Authored and submitted original research articles for publication in peer-reviewed journals, disseminating findings.

Certificates

Data Wrangling in Excel using Power Query

Dec 2025

LinkedIn Learning

Clinical Research Coordination - Badge I

Nov 2025

Rutgers health

Master Microsoft Power BI

Oct 2025

Alison University

PMP Certification Exam Prep Course 35 hours contact PDU

Sep 2025

Technical Institute of America

Foundations of Good Clinical Practice

Jun 2025

CCRPS

Good Clinical Practice

May 2025

NIDA-Clinical Trial Network

Professional Certificate in Project Management

Mar 2025

MTF Insititute for Management, Technology and Finance

Learning Microsoft Project

Sep 2024

LinkedIn Learning

GLP Study Director and Principal Investigator Training

Jan 2024

Society for Quality Assurance

Data Science Part of 9-course IBM Data Science Professional Certificate

Jan 2021

IBM (Coursera)

Design and Interpretation of Clinical Trials

Jan 2021

Johns Hopkins University (Coursera)

CRISPR and Transgenic Workshop – Genetically Engineered Murine Model Core (GEMM)

Jan 2018

University of Virginia

Introduction to Flowcytometry

Jan 2014

University of Virginia, Flowcytometry Core

Awards

Team Care Award Q2 2022

Jun 2022

Genesis Drug Discovery and Development

Awarded for outstanding team care and collaboration during Q2 2022.

Superlative Service Award

Dec 2021

Eurofins PSS Insourcing Solutions

Recognized for exceeding client's expectations and providing superlative service.

Skills

Bioanalytical Techniques

Ligand Binding Assays (LBA), Mesoscale Discovery (MSD), ELISA, Luminescence Assays, Flow Cytometry, qRT-PCR, Immunofluorescence, Confocal Microscopy, FRET, xCELLigence, Seahorse Extracellular Flux Assay.

In Vitro Techniques

Mammalian Cell Culture, Transient Transfection, Stable Transfection, Nucleofection, Viral Transduction, Targeted Gene Knockdown, Gene Over-expression, Plasmid Vectors, siRNAs.

Molecular Biology

Cistronic Plasmid Vectors, 2A Plasmid Vectors, Site-Directed Mutagenesis, Lentivirus Production, Lentivirus Purification.

Regulatory Compliance

GLP (Good Laboratory Practice), USDA, FDA, 21 CFR Part 11, IACUC.

Project Management & Data Tools

EndNote, FileMaker Pro 5, SharePoint, MS Project, MS Office (Word, Excel, PowerPoint), GraphPad Prism, SPSS, Sigma Plot, CorelDraw, Adobe Illustrator, ImageJ, Metamorph.

Scientific Expertise

Drug Discovery & Development, Preclinical Efficacy, DMPK (Pharmacokinetics/Pharmacodynamics), Bioanalysis, Toxicology, Oncology, Immunology, Neuroscience, Metabolism, Cell Therapy, Gene Therapy, Biomarker Analysis, Disease Model Development, Data Interpretation, Scientific Writing, Grant Writing, Technology Transfer, Assay Development, Method Validation.

Leadership & Communication

Cross-functional Team Leadership, Stakeholder Management, Client Relationship Management, Scientific Negotiation, Mentorship, Strategic Planning, Business Development.

In Vivo Research

Preclinical Animal Models (Rat, Mice, Monkeys), Fat Mass Analysis, Lean Mass Analysis, Metabolic Cage Studies, Glucose Tolerance Test (GTT), Insulin Tolerance Test (ITT), Whole Animal Bioluminescent Imaging (IVIS), Fluorescent Imaging (IVIS), Tissue-Specific Gene Knockout (Cre/Lox), Adeno-Associated Virus (AAV) mediated oligonucleotide/siRNA.

Publications

Pannexin 1 activation drives neutrophil recruitment in a murine model of non-ischemic heart failure induced by isoproterenol.

Cir Res

Oct 2023

Adaptive thermogenesis in brown adipose tissue involves activation of pannexin-1 channels.

Mol Metab

Feb 2021

Authored research on Pannexin-1 channels' role in adaptive thermogenesis in brown adipose tissue.

Liver-specific loss of Perilipin 2 alleviates diet-induced hepatic steatosis, inflammation, and fibrosis.

Am J Physiol Gastrointest Liver Physiol.

Mar 2016

Co-authored research demonstrating Perilipin 2's role in alleviating hepatic steatosis.

Disabled homolog 2 controls macrophage phenotypic polarization and adipose tissue inflammation.

J Clin Invest.

Feb 2016

Co-authored research on Disabled homolog 2's control over macrophage polarization and inflammation.

Structural and functional assessment of perilipin 2 lipid binding domain(s)

Biochemistry

Oct 2014

Co-authored research on structure-function relationship of lipid droplet protein, perilipin 2

Plin2 inhibits cellular glucose uptake through interactions with SNAP23, a SNARE complex protein.

PLoS One.

Sep 2013

Authored research on Plin2's inhibition of glucose uptake through SNAP23 interaction.

Direct interaction of Plin2 with lipids on the surface of lipid droplets: a live cell FRET analysis.

Am J Physiol Cell Physiol.

Oct 2012

Co-authored research on Plin2's direct interaction with lipids on lipid droplets using FRET analysis.

The phospholipid monolayer associated with perilipin-enriched lipid droplets is a highly organized rigid membrane structure

Am I Physiol Endocrinol Metab

Nov 2011

Co-authored research on structural organization in lipid droplet membrane

Mixed lineage kinase 3 modulates β-catenin signaling in cancer cells.

J Biol Chem.

Oct 2011

Co-authored research on Mixed lineage kinase 3's modulation of β-catenin signaling in cancer.

Glycogen Synthase Kinase-3beta regulates Snail and beta-catenin during gastrin-induced migration of gastric cancer cells

J Mol Signal

Jul 2010

Mixed lineage kinase-3/JNK1 axis promotes migration of human gastric cancer cells following gastrin stimulation

Mol Endocrinol

Mar 2010

Co-authored research on elucidating the mechanism(s) of gastrin mediated cancer cell metastasis.

Caspase-mediated cleavage of beta-catenin precedes drug-induced apoptosis in resistant cancer cells

J Biol Chem

May 2009

Authored research on mechanism(s) of drug resistance underlying cancer cell survival.

In vivo spermatotoxic effect of chromium as reflected in the epididymal epithelial principal cells, basal cells, and intraepithelial macrophages of a nonhuman primate (Macaca radiata Geoffroy)

Fertil Steril

Oct 2006

Authored research on altered epididymal structure and function causing reproductive toxicity due to chromium exposure.

Reproductive toxicity of chromium in adult bonnet monkeys (Macaca radiata Geoffrey). Reversible oxidative stress in the semen

Toxicol Appl Pharmacol

Sep 2006

Authored research on oxidative stress mechanism(s) induced reproductive toxicity.

Microcanalization in the epididymis to overcome ductal obstruction caused by chronic exposure to chromium - a study in the mature bonnet monkey (Macaca radiata Geoffroy)

Reproduction

Jul 2004

Authored research on structural changes in epididymis induced by chronic chromium exposure

4(R)-5, 10, Seco 19-Norpregna 4,5 Diene 3, 10, 20 Trione (Seco), an Inhibitor of Epididymal 5α-Reductase Arrests Sperm Forward Motility in Wistar Rats

J Endocrinol Metab

Dec 1999

Co-authored research on the development of a novel contraceptive candidate

Impact of altered thyroid hormone status on prostatic glycosidases

Int J Androl

Jun 1998

Co-Authored research on prostatic functions with altered thyroid hormone status.

Prostate-thyroid axis: stimulatory effects of ventral prostate secretions on thyroid function

Prostate

Jun 1998

Co-authored research on the identification of a novel prostate-thyroid axis.