GxP Bioanalysis  ·  LC-MS / DMPK  ·  ADC Characterisation  ·  Richmond, VA

16 GxP programmes.
Zero audit findings.
Data in client INDs.

Principal Investigator across 16 regulated LC-MS/MS programmes for five global biopharmaceutical clients. ADCs, large molecules, small-molecule DMPK, preclinical through Phase III. Every package delivered to submission standard, on time, without a query coming back.

ICH Q2 · Q6B · M10  ·  Orbitrap Exploris · Sciex 7500 · Altis+  ·  Data supporting client IND / BLA submissions  ·  Available for consulting

Discuss Your Project See Case Studies →
16
GxP-Regulated Programmes as PI
0
Audit Findings Across All Programmes
28+
Peer-Reviewed Publications
14+
Years Spanning Discovery → Phase III
About

The analytical PI your clinical programme needs, but doesn’t have in-house.

As Principal Investigator at Thermo Fisher Scientific (PPD), I lead 16 GxP-regulated LC-MS/MS programmes for five global biopharmaceutical clients: ADCs, biotherapeutics, small-molecule DMPK, preclinical through Phase III. Every programme has cleared regulatory review without audit findings. The analytical data and reports I generate go directly into client IND and BLA submissions. That’s the job.

Before the CRO, I spent two years building the University of Virginia School of Medicine metabolomics core from nothing. No platform, no SOPs, no reference materials to start with. Two years later: 50+ active research programmes, a 1,610-spectrum MS/MS library on MassBank, papers in Nature Metabolism and Science Advances. Before that, a full phenotypic drug discovery campaign at Nebraska: 43,783 compounds, integrated multi-omics MoA, US patent granted. That work built the instincts the regulated side runs on.

“The best analytical scientists I’ve known could tell you not just what the data said, but what it meant for the programme. That’s the kind of scientist I’ve tried to be.”

I’m available for consulting, advisory work, and senior positions. If your method won’t transfer, your ADC programme is missing an analytical strategy, or your regulatory package keeps coming back with queries, get in touch.

Currently accepting: Consulting  ·  Advisory Board  ·  Senior Roles

Current Position

R&D Scientist / PI, Bioanalysis
Thermo Fisher Scientific / PPD
Nov 2022 – Present · Richmond, VA

16 GxP programmes · 5 global pharma clients · 0 audit findings · data and reports supporting client IND/BLA submissions

Education

PhD, Chemical & Biological Engineering
University of Sheffield, UK · 2006–2010

MSc, Botany
Nagpur University, India

Credentials

National Overseas Fellow (Govt. of India)
NSF-EPSCoR Principal Investigator
US Patent 10351883
ORCID: 0000-0002-8955-3300

Find Me

LinkedIn Scholar GitHub ORCID
Services

Three problems I’ve
spent years actually solving.

Clients include global biopharma sponsors, bioanalytical CROs, and academic medical centres. These are problems, not techniques.

01 / LC-MS & DMPK
Method Development & Validation

Your method isn’t behaving, your timeline is slipping, or your team doesn’t have the LC-MS expertise to get a GxP-compliant package over the line. I’ve run 16 programmes covering ADCs, large molecules, and small molecule DMPK. I know where these projects break down and how to fix them.

  • ADC characterisation (peptide mapping, DAR, HCP)
  • DMPK/ADMET method development & MetID
  • GxP/GLP validation aligned with ICH Q2, Q6B, M10
  • Analytical strategy for client IND/BLA submissions
  • Orbitrap Exploris, Sciex 7500/6500, Altis+
02 / HTS DESIGN
Phenotypic Drug Discovery

You need a phenotypic screen designed and validated, or you’ve got hits and need someone who can run the full cascade without cutting corners: dose-response, cheminformatics SAR, multi-omics mechanism work that holds up under scrutiny. I’ve done this at scale. 43K compounds, Z′ = 0.78, patent granted.

  • Phenotypic assay design & Z′ validation (96-/384-well)
  • Hit-to-lead: 4PL dose-response, EC₅₀, MPO profiling
  • SAR by cheminformatics (ChemMine, ChemAxon, Spotfire)
  • Multi-omics MoA: proteomics + RNA-seq + metabolomics
  • ACLY, DGAT, lipid metabolism target expertise
03 / MULTI-OMICS
Study Design & Data Science

Your team ran the experiment. The data came back. Now everyone’s staring at a heatmap wondering what to tell the programme team. I design multi-omics studies around a specific mechanistic question from the start, then build R pipelines that give you an answer, not a figure.

  • Untargeted metabolomics & lipidomics study design
  • Proteomics (DDA/DIA/TMT) integration with metabolomics
  • R pipelines: PCA/PLS-DA, pathway analysis, MixOmics
  • ¹³C SIRM flux analysis, target engagement (CETSA/LiP-MS)
  • Platform-agnostic: GC-MS, LC-MS/MS, FT-ICR-MS, NMR
What Clients Say

From the people who
signed off the work.

References available on request. Names withheld where NDA applies.

“The analytical data and reports Nishikant delivered went directly into our IND without a single query coming back. His feel for where GxP programmes go wrong, and how to pull them back on track, isn’t something you find often.”

PROGRAMME DIRECTOR
Top-5 Global Biopharma · NDA applies

“He built the ADC peptide mapping workflow from nothing and had us exporting MRM transitions to both Thermo and Sciex in under a month. When the method went to the client site, it worked first time.”

SENIOR SCIENTIST, BIOANALYSIS
Global CRO · Reference available on request

“He took our metabolomics core from zero to 50 active programmes in under two years. The SOPs and R pipelines he built are still what the department runs on.”

RESEARCH DIRECTOR
University of Virginia School of Medicine
How I Engage

Three ways to work together.
One starting point.

A 30-minute call is always free. Most engagements are scoped within a week.

01 / Method Rescue
Focused, fixed-scope.
Fast.
TYPICAL DURATION: 3–8 WEEKS

Your method is broken or the timeline is slipping. I come in, diagnose it, and deliver a validated, submission-ready method with a full technical report. No retainer.

Typical Deliverables
  • Validated method + full validation report
  • Analytical strategy memorandum
  • GxP-ready SOP package
02 / Programme Support
Senior oversight
across a live programme.
TYPICAL DURATION: 3–6 MONTHS

You need a senior analytical voice on the programme. Someone who can review data, sit in on team calls, and make the right scientific call when the pressure is on. Fixed retainer, rolling.

Typical Deliverables
  • Weekly technical review & data sign-off
  • Regulatory strategy input
  • Analytical data package review for client IND/BLA submissions
03 / Strategic Advisory
Expert opinion.
On the record.
ONGOING / BOARD OR PROJECT BASIS

Named scientific reviewer for regulatory submissions, SAB membership, or expert review of analytical data packages. Written opinions when needed.

Typical Deliverables
  • Written scientific opinion / expert review
  • SAB membership & advisory meetings
  • Named analytical reviewer, submissions
Start with a 30-minute call →
Case Studies

What the client walked
away with. Specifically.

Three programmes: what was broken, what I did, and what the client submitted to regulators.

01

ADC & Large Molecule Bioanalysis Pipeline

Thermo Fisher / PPD · 2022–Present · 16 programmes, 5 global clients · Preclinical → Phase III

+

The Brief

Five global biopharmaceutical clients needed GxP-compliant LC-MS/MS analytical packages for ADCs, biotherapeutics, and peptide drugs. Tight timelines, regulatory scrutiny at every stage.

What I Did

  • PI across 16 programmes: peptide mapping, ADC characterisation on Orbitrap Exploris 240/480 and Sciex Altis+
  • GLP/GxP strategies aligned with ICH Q2, Q6B, M10. Data written to submission standard throughout
  • Implemented Hamilton Nimbus automation and R-based reporting pipelines
  • Built ADC Peptide Mapper (R-Shiny) for MRM transition export to Thermo/Sciex

What the Client Got

  • GxP-compliant analytical data and technical reports used by the client in IND and BLA submissions. No queries came back
  • Zero audit findings across all 16 programmes under GLP/GxP inspection
  • Methods transferred to three client laboratory sites without modification
  • ADC Peptide Mapper adopted by client teams for ongoing MRM work
ADC CharacterisationGxP / GLPOrbitrap ExplorisICH M10CMC
02

43K-Compound Phenotypic HTS: From Pilot to Patent

Univ. of Nebraska–Lincoln · 2011–2019 · US Patent 10351883 · $725K in grants

+

The Brief

Identify small molecules that enhance lipid metabolism during active cell growth, a bottleneck in biofuel production and a useful model for human lipid storage disorders including NASH. No validated assay platform existed.

What I Did

  • Designed and validated Nile Red/OD assay from scratch; Z′ = 0.68 at pilot (classified “excellent”), scaled to Z′ = 0.78 at full campaign (43K, 124 × 384-well)
  • 243 confirmed hits across 5 scaffolds; 4PL dose-response, Tanimoto SAR, MPO ranking in R
  • Integrated TMT proteomics, RNA-seq, and metabolomics to map the ACLY/DGAT/ARF1 axis

Outcome

  • US Patent 10351883, granted July 2019, commercially relevant scaffolds
  • $725,000 in external grant funding from two independent sources
  • 5 peer-reviewed publications including two Plant Physiology Highly Accessed papers
  • Full dataset archived in PubChem BioAssay (AIDs 1159536/1159537)
Phenotypic HTSSAR / CheminformaticsMulti-Omics MoAUS Patent
03

Metabolomics Core: Built and Scaled in 24 Months

University of Virginia, School of Medicine · 2020–2022 · 50+ programmes

+

The Brief

Build a fully operational metabolomics and lipidomics core for UVA School of Medicine from scratch. No existing platform, no SOPs, no reference materials. Support programmes across metabolic disease, infectious disease, and microbiome science.

What I Did

  • Implemented and validated LC-MS/MS, GC-MS, and lipidomics workflows from scratch with full SOP documentation
  • Built a 500-compound metabolite reference library; deposited 1,610 MS/MS spectra to MassBank of North America
  • Developed R-based bioinformatics pipelines for PCA/PLS-DA, pathway enrichment, and multi-omics integration
  • Led analytical harmonisation across TUMI partner institutions

What the Client Got

  • 50+ active research programmes supported within 24 months of launch
  • Publicly available 1,610-spectra MS/MS reference library via MassBank
  • Publications in Nature Metabolism, mSystems, Metabolomics, and Liver International
Metabolomics CoreLipidomicsMassBankTUMI
Selected Publications

Published science that
underpins the consulting work.

28+ peer-reviewed papers. The analytical rigour is on the record. Full list on Google Scholar  ·  ORCID: 0000-0002-8955-3300

2026
Science AdvancesScience

Ampk alpha2 T172 activation dictates exercise performance and energy transduction in skeletal muscle

Montalvo RN, Li X, Wase N et al.  Sci. Adv. 12(9):eaeb3338

2023
Nature MetabolismNature

Phagocytosis in the retina promotes local insulin production in the eye

Iker Etchegaray J, Kelley S, …, Wase N et al.  Nat. Metab. 5(2):207–218

2022
Nature CommunicationsNature

Genome of Paspalum vaginatum and the role of trehalose mediated autophagy in increasing maize biomass

Sun G, Wase N, Shu S et al.  Nat. Commun. 13(1):7731

2019
Plant Physiology★ Multi-Omics MoA

Remodeling of Chlamydomonas metabolism using synthetic inducers results in lipid storage during growth

Wase N, Tu B, Rasineni GK et al.  Plant Physiol. 181(3):1029–1049

2017
Plant PhysiologyHighly Accessed★ Full HTS Campaign

Identification and metabolite profiling of chemical activators of lipid accumulation in green algae

Wase N, Tu B, Allen JW, Black PN, DiRusso CC  Plant Physiol. 174(4):2146–2165  PMID: 28652262

2018
Progress in Lipid Research

Innovations in improving lipid production: Algal chemical genetics

Wase N (corresponding author), Black P, DiRusso C  Prog. Lipid Res. 71:101–123

2014
Journal of Proteome ResearchHighly Accessed

Integrated quantitative analysis of nitrogen stress response in Chlamydomonas reinhardtii using metabolite and protein profiling

Wase N, Black PN, Stanley BA, DiRusso CC  J. Proteome Res. 13(3):1373–1396

PAT
US Patent · 2019Patent

🏛 US Patent 10351883 / US20200071735A1: Compounds for Increasing Lipid Synthesis and Storage

DiRusso C, Wase N  ·  Filed: April 25, 2016  ·  Granted: July 16, 2019

View all 28+ on Google Scholar →
Open-Source Tools

Tools built because
they were needed.

Built because the right tool didn’t exist.

DMPK Suite

MetID DMPK-ADME Suite v3.1

A 13-module browser-based DMPK platform. MetID with 50 Phase I/II biotransformation rules, NCA pharmacokinetics, ADMET traffic-light scoring, three-engine MS² prediction, FDA MIST regulatory reporting. Currently under internal review. Happy to walk you through it.

MetIDNCA PKADMETMS² PredictionFDA MIST
MetID DMPK-ADME Suite demo: Ibuprofen Phase I/II study
Get in touch for access →
ADC Tools

ADC Peptide Mapper + DAR/PK Tracker

Two R-Shiny tools for ADC bioanalysis. Peptide Mapper finds unique signature peptides and exports MRM transitions for Thermo or Sciex. The DAR/PK Tracker calculates in vivo average DAR over time and runs NCA via PKNCA.

ADC_Peptide_Mapper ADC_DAR_PK_app
Launch ADC Peptide Mapper →
MS/MS Library

MS/MS Spectral Library

1,610 high-quality ESI(+) MS/MS spectra covering 509 unique metabolites, IROA-validated and SPLASH-indexed. Deposited to MassBank of North America as a freely available community resource. Good reference data should be shared, not hoarded.

MassBank of North America →
Get in Touch

What does your
problem look like?

Most analytical problems aren’t mysterious. A method that won’t transfer. A screen drowning in false positives. A regulatory data package that keeps coming back with queries. An omics dataset that produced a beautifully formatted heatmap and zero actionable biology. If any of that sounds familiar, let’s talk.

✉nishikant.wase@gmail.com
📍Richmond, VA  ·  Happy to travel or work remotely
💼linkedin.com/in/nwase
🔗ORCID: 0000-0002-8955-3300

How We Might Work Together

  • Consulting: Project-based analytical strategy & execution
  • Advisory: Scientific advisory board, expert peer review
  • Method development: Short-term, hands-on engagement
  • Full-time: Senior Scientist / Principal Scientist roles genuinely considered
Curriculum Vitae
Full scientific CV including publications,
grants, patents, and regulatory experience.
↓  Download CV