Neeraj Tiwari, Ph.D.

 +1 (203)-909-1349
email: tiwarineeraj@gmail.com
LinkedIn: http://www.linkedin.com/in/tn75

• Clinical scientist with >7 years of expertise in bioanalytical method development, validation and clinical data delivery
• Expert in developing and establishing fit-for-purpose biomarker assays using internal resources or third-party vendors.
• Successful in creating strong biomarker strategies aligned with leadership, delivering quality results within a predictable
financial framework.
• Experienced in managing relationships with key stakeholders, including clinical study leads, project managers, and platform
representatives, to achieve portfolio targets.
• Proven track record of leading multiple clinical biomarker projects in early clinical development and contributing to study
protocol development with a focus on sample collection, processing, and data reporting.
• Skilled in implementing robust quality control measures in method development, ensuring high-quality instrument operations
and clinical data reporting.
• Capable of writing bioanalytical reports and supporting clinical leads to achieve milestones, while also managing clinical
assay scientists to deliver timely and high-quality results.

 Biomarker Assay Feasibility  Clinical Bioanalytical Method  Bioanalytical Method

Assessment (FC & LBA)
 Biomarker Assay Validation
 Analytical Instruments
management (FC & LBA)
 Process Improvement
 Budget Management
Development (FC & LBA)
 Clinical Bioanalytical Method
Validation (FC & LBA)
 Clinical Sample Management
 Vendor Management/Supply
chain inventory management
 Lab remodeling & Setup
Plan/Protocol & Report writing
 Bioanalytical Study Plan &
Report Writing
 SOPS/Work instructions/Test
Method Development & writing
 Quality Management (Risk
Based)

Clinical Development Experience:

Pfizer New Haven CRU, New Haven, CT 2018-present
Clinical Biomarker Assay Lead

 Established fit for purpose biomarker assays internally and tech transfer the protocol to third-party vendors.
 Evaluated new technologies and assay platforms for clinical biomarker use.
 Aligned with leadership to create a strong biomarker strategy that delivers quality results within a predictable financial
framework.
 Managed relationships with clinical study lead, project managers, platform representatives, and internal and external
stakeholders to achieve portfolio targets in oncology, rare diseases, inflammation/immunology, and internal medicine.
 Developed new technologies to streamline biomarker workflows and continuously improve clinical biomarker programs
using ligand binding-based methods on various platforms.
 Drove innovation to deliver clinical results within time constraints and led multiple clinical biomarker projects in early
clinical development.
 Contributed to study protocol development (IND application), focusing on sample collection, processing, and data reporting.
 Implemented robust quality control measures in method development and ensure quality instrument operations and
maintenance, including sample preparation, analysis, and clinical data reporting.
 Submitted bioanalytical reports and support clinical study team leads in achieving milestones.
 Ensured timely results delivery to cross-functional teams and manage clinical assay scientists to achieve high-quality assay
performance.
 Developed internal metrics for effective quality performance monitoring, support data management to streamline data
delivery with a focus on quality, and lead in drafting operational, strategic, and financial plans for study protocols with a
focus on biomarkers.

Pfizer New Haven CRU, New Haven, CT 2016 - 2018

Biomarker Assay Scientist (Consultant)
• Organized and maintained the Biomarker Lab to ensure cleanliness, safety, adequate inventory, and required quality
documentation for instruments and bioanalytical materials.
• Supported the assay development, manage the clinical trial samples, test the clinical samples as per the SOPs, generated the
quality data and reports including the QCs the data and delivered the quality results to clinical data team/study teams.
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 • Managed the bioanalytical instruments records on daily, weekly and monthly basis. Delivered the maintenance records
during FDA/Internal inspection in unannounced visit and accountable for query response.
• Handled, processed, tested, and managed human biospecimens in compliance with GCP and GCLP regulations.
• Supported best approach to complex issues, notified the noncompliance issues, and facilitated the leadership to resolve lab
noncompliance issues.
• Applied scientific rigor to troubleshoot method.
• Managed the CRO/external vendor to sustain the high-quality bioanalytical method standards and timely transfer of
data/resources.

Research Experience:
Yale School of Medicine, New Haven, CT 2009 – 2015
Research Scientist, Cancer Cell Biology 2014 - 2015
 Conducted drug target identification and characterization using a small molecule inhibitors library.
 Generated and validated protein expression vectors (MBP-tagged, 12xHis/6xFlag/HA/V5-tagged) by imaging the subcellular
target in both knockout and wild-type mammalian cell lines using confocal microscopy.
 Established transient knockout cell lines through the use of siRNA/shRNA techniques.
 Designed novel mutations for efficient expression of recombinant soluble and membrane proteins.
 Analyzed high expression clones in CHO and 293T cells using a range of methodologies.
 Improved the yield of recombinant protein expression in batch culture by implementing new techniques and tools.
 Provided hands-on training to graduate and undergraduate students in molecular and cell biology.
Associate Research Scientist, Cell Biology
 Executed gene editing through siRNA/shRNA-mediated methods and designed 24 site-directed mutagenesis constructs for a
single gene using alanine scanning.
 Coordinated and aligned the cross-functional team from diverse scientific backgrounds (biophysics, cell biology, protein
chemistry, and immunology).
 Supervised a team of up to 5 members for in-frame cloning, primer walk sequencing, and protein expression in mammalian
cells and bacterial expression systems.
Significant Accomplishments:
 Uncovered the protein network involved in Golgi complex function through yeast two-hybrid, GST pull-down, and co-
immunoprecipitation methodologies.
 Proved the functional role of an uncharacterized Golgi-tether protein on the cellular and functional organization of the Golgi
complex through RNAi-mediated gene silencing and by overexpressing its functional domain.
 Designed and executed a strategy to uncover the functional relationships of complex protein networks through multiple
methodologies.

Post-Doctoral Associate, Cell Biology 2009 - 2010

• Designed and executed a strategy for the single-step purification of membrane proteins for single molecule bioassays.
• Conceived and executed a project for single molecule FRET (Fluorescence Resonance Energy Transfer).
• Facilitated the thiol-specific conjugation of a fluorescent probe to a recombinant membrane protein.
• Established optimal conditions for the visualization of single molecule proteins and developed bio-conjugates for FRET-
based assays.
INSERM U1149, Paris, France 2005 - 2008
Post-Doctoral Fellow, Immunology
• Spearheaded projects aimed at investigating the molecular mechanisms of mast cell exocytosis.
Significant Accomplishments:
 Established a strategy for enriching mouse mast cells from bone marrow, resulting in a single step enrichment with 97%
purity, characterized by flow cytometry (FACS).
 Unveiled the pivotal role of v-SNARE and t-SNARE tether proteins in mast cells, providing new insights into the critical
junction between protease-associated compartments and cytokine/chemokine-associated cellular compartments.
 Collaborated with international research labs in Singapore, India, Germany, Israel, and Canada.
 Authored and co-authored 4+ publications in top scientific journals.
 Mentored one PhD student.

German Cancer Research Center (DKFZ), Heidelberg, Germany 2001 - 2005

Ph.D. Immunology

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 Thesis Title: Characterization of Antigen Processing and Presentation by Peptide-linked MHC Class I Molecules.
Significant Accomplishments:

• Discovered a novel antigen cross-presentation route for the MHC class I pathway.
• Demonstrated ER-independent MHC class I antigen presentation, providing valuable insights for drug discovery.
• Presented key findings as an oral presentation at the Annual Meetings of the German Society of Immunology in Marburg
(2002) and Kiel (2005).
• Completed advanced courses in Immunology at Stanford University, USA as part of the American Association of
Immunologists (AAI), in 2004.

Technical Expertise:
Molecular Biology and Immunology:
• Proficient in a range of molecular biology techniques, including PCR, RT-PCR, siRNA, shRNA and miRNA.
• Extensive experience with gene cloning, sub-cloning, sequencing, mutagenesis, and expression.
• Knowledgeable in microbial protein expression systems, from 96 well plates to 24 liters pilot projects.
• Experienced in producing polyclonal/monoclonal antibodies (ascites or hybridoma) and performing affinity purification
(small scale). Skilled in characterizing proteins using ELISA, western blot, and imaging.
• Adept at aseptic isolation, propagation, and differentiation of primary cells from mouse bone marrow, thymus, spleen, and
lymphoid tissue.

Cell Biology and Biochemistry:

• Experienced in mammalian cell culture and cell line development, including media formulation.
• Skilled in small scale recombinant protein expression using mammalian cell lines (293T/S or CHO).
• Bioanalytical assay development and method validation using techniques such as MSD, ELISA, Luminex, Automated
ELISA, flow cytometry, IHC, and PCR.
• Experienced in imaging techniques including confocal and electron microscopy.
• Skilled in proteomics and protein production, purification using ion exchange, size-exclusion and affinity chromatography
(Nickel, GST, Protein A/Protein G, and nano-tag).
• Experienced in protein purification, optimization, and functional validation in research lab (non-GLP).

Academic Fellowships:
• DKFZ Doctoral fellowship, Heidelberg, Germany, FRM Post-doctoral fellowship, Paris, France
• Boehringer Ingelheim travel grant, Germany
Selected Publications:
• Shualyang Jing, Jingkai Gao, Neeraj Tiwari et al. Golgin45 SUMOylation contributes to PML nuclear body formation
during heat shock response. 2022 (Under peer review).
• Xihua Yue, Neeraj Tiwari, et al. Tankyrase-1-mediated degradation of Golgin45 regulates glycosyltransferase trafficking
and protein glycosylation in Rab2-GTP-dependent manner. Commun Biol 2021. 4: 1370
• Neeraj Tiwari, Xihua Yue, et al: Golgin45-Syntaxin5 interaction contributes to structural integrity of the Golgi Stack
Science Report. 2019. 9: 12465.
• Iris K. Madera-Salcedo, Luca Danelli, Neeraj Tiwari et al: Tomosyn-1 is upregulated by IgE and functions as a PKCδ-
regulated fusion clamp in mast cell degranulation Science Signaling. 2018. 11: 537
• Feng Li, Neeraj Tiwari, James Rothman and Frederic Pincet: Kinetic barriers to SNAREpin assembly in the regulation of
membrane docking/priming and fusion. PNAS. 2016. 113 10536–10541
• Neeraj Tiwari, Intaek Lee, Myun Hwa Dunlop, Morven Graham, Xinran Liu and James E. Rothman: Membrane adhesion
dictates Golgi stacking and cisternal morphology. PNAS. 2014. 111-1849-54
• Neeraj Tiwari, Cheng-Chun Wang et al: VAMP-8 segregates mast cell-preformed mediator exocytosis from cytokine
trafficking pathways. Blood. 2008. 111, 3665-74
• Neeraj Tiwari, Natalio Garbi, et al: A transporter associated with antigen-processing independent vacuolar pathway for the
MHC class I-mediated presentation of endogenous transmembrane proteins. J Immunol. 2007. 178, 7932-42
• Cristiana Brochetta, Francesca Vita, Neeraj Tiwari, et al. Involvement of Munc18 isoforms in the regulation of granule
exocytosis in neutrophils. Biochim Biophys Acta. 2008. 1783, 1781-91