Analytical Development Leader

Eric J. Yearley, PhD

Biologics · Protein Therapeutics · mAbs · ADCs · Antigens · AAV Gene Therapy · mRNA Vaccines

Distinguished leader with 13+ years of comprehensive experience in therapeutics and vaccines analytical development, specializing in mass spectrometry, biophysical characterization, separations, cell-based potency assays and molecular biology methods. Proven expertise in developing and implementing analytical control strategies for complex biologics across multiple modalities including monoclonal antibody therapeutics, antigen-based vaccines, nucleic acid/nanoparticle platforms and viral vector gene therapy products from early-phase development through Phase 3 clinical.

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Eric J. Yearley, PhD
13+
Years of Experience

Leading analytical development for cutting-edge biologic modalities

560+
Total Citations

Peer-reviewed publications in leading scientific journals

7+
Programs

Majority contributor or leader of analytical control strategies for clinical and platform programs

01 — About

Building the analytical
foundation for breakthrough
therapeutics

Throughout my career, I have built and led analytical development organizations responsible for characterizing some of the most complex therapeutic modalities in the pharmaceutical industry. From recombinant protein vaccines to cutting-edge mRNA-LNP platforms and AAV gene therapies, I've developed the analytical strategies that enable these life-changing treatments to reach patients.

My expertise spans the complete analytical lifecycle—from early method development through late-stage validation, technology transfer, and commercial implementation. I take pride in building high-performing teams, implementing digital transformation initiatives, and driving operational excellence while maintaining rigorous regulatory compliance.

With a PhD in Chemistry from the University of Toledo (2007) under A. Alan Pinkerton, specializing in X-ray Crystallography, and postdoctoral experience at Genentech, I bring a deep scientific foundation combined with practical industry experience across companies including CSL Seqirus, BridgeBio, Precision Biosciences, GlaxoSmithKline, and MacroGenics.

02 — Industry Pulse

AI in Biotech & CMC

News, papers, and discussions on AI in pharma and CMC developments across the biotech industry

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03 — Expertise

Areas of Expertise

Specialized capabilities across the analytical development lifecycle

01

Mass Spectrometry

Expert in LC-MS, LC-MS/MS, peptide mapping, and intact mass analysis for comprehensive protein characterization and post-translational modification monitoring.

02

Analytical Control Strategy

Development of comprehensive ACS frameworks aligned with ICH Q14, including CQA assessment, method lifecycle management, and specification setting per ICH Q6B.

03

Method Validation & Transfer

End-to-end method qualification and validation per ICH Q2(R2), with extensive experience in global CDMO transfers and multi-site implementation.

04

Bioassay Development

Cell-based potency assays, ELISA, immunofluorescence, and FACS-based methods for functional characterization of biologics and vaccines.

05

Molecular Biology Methods

qPCR, ddPCR, and nucleic acid quantification methods for mRNA and viral vector characterization, including integrity and potency assessments.

06

Digital Transformation

ELN/LIMS implementation, laboratory automation initiatives, and AI-assisted writing and documentation achieving 30-50% efficiency improvements.

04 — Experience

Professional Journey

July 2023 — Present

CSL Seqirus

Associate Director: Cell, Molecular, Separations & CMC Analytical

Holly Springs, NC

  • Direct 13+ member analytical development organization with 5 direct reports and full P&L responsibility
  • Co-delivered analytical control strategies for 3 clinical and 3 platform programs enabling critical product advancements
  • Achieved 10x increase in fragment analyzer assay throughput and 7x increase in potency assay throughput
  • Led ELN implementation reducing deviations from 150/year to 2-3/year (~98% reduction)
  • Justified >$1M annual CAPEX and headcount requests aligned with portfolio priorities

September 2019 — July 2023

BridgeBio

Associate Director - Principal Scientist

Raleigh, NC

  • Managed 11+ direct and indirect reports; served on CMC leadership team
  • Lead AD for novel pre-IND viral vector program—achieved IND-enabling tox material in 6 months
  • Authored CMC sections for multiple IND submissions and FDA annual updates
  • Co-led design of cGMP QC release testing facility for clinical batch release
  • Implemented QbD framework defining CQAs, CPPs, and comparability strategy

March 2019 — August 2019

Precision Biosciences

Senior Scientist

Durham, NC

  • Co-led development of assays to quantitate critical nucleic acid species for gene therapy programs
  • Developed assay to quantify 5' capping species using reverse phase ion pairing LC-MS
  • Assisted in determination of CQAs and analytical techniques from QTPP

2016 — 2019

GlaxoSmithKline

Expert Scientist

Rockville, MD

  • Expert scientific and matrix leader for LC-MS, separations, biophysical and computational activities
  • Critical analytical contributor to early clinical development of Arexvy (RSVPreF3 OA), GSK's RSV vaccine
  • Co-led design of Good Laboratory Practice Program; authored 10 GLP guidance documents
  • Awarded two Silver Performance Awards for vital scientific contributions

2012 — 2016

MacroGenics, Inc.

Scientist I

Rockville, MD

  • Established and managed protein LC/MS program for bispecific antibody and ADC characterization
  • Led implementation of SEC-MALS and DSC technologies for enhanced characterization
  • Supported computational modeling for antibody design through analytical insights

05 — Impact

Case Studies

Transformative analytical solutions that enabled program advancement

CSL Seqirus

Flow Cytometry Potency Assay Optimization

A critical potency assay was creating a bottleneck in vaccine development, with 200-sample campaigns requiring 8 months to complete—threatening program timelines for late-stage advancement.

Through rigorous scientific analysis, my team demonstrated that 2-3 data points in the linear region provided statistically equivalent results to full dose-response curves. This insight enabled a complete workflow redesign, ensuring a critical initiative was finished within the established time frame while maintaining 98% Right-First-Time quality.

7× Throughput Increase
8→2 Months for 200 Samples
98% RFT Maintained

BridgeBio

Gene Therapy Analytical Platform

An AAV9 gene therapy program required transferring a comprehensive analytical platform to multiple CDMOs—including methods to confirm enzyme expression and demonstrate functional potency of the therapeutic protein.

Led multi-site technology transfer of the complete analytical suite: LC-MS methods for protein characterization, SEC and CE methods for purity, and a two-stage potency approach—first confirming transgene expression, then validating enzymatic activity. Achieved IND-enabling tox material in 6 months.

RMAT FDA Designation
4 Special Designations
6 mo To IND-Enabling

CSL Seqirus

Fragment Analyzer Platform Implementation

Late-stage testing demands required dramatically higher sample throughput than existing agarose gel electrophoresis could deliver—only 20 samples per week with low resolution that risked program timelines.

Led transition to high-resolution Fragment Analyzer technology, developing and validating methods that replaced manual gel-based workflows with automated capillary electrophoresis. The new platform enabled high-resolution nucleic acid characterization at scale.

25× Throughput Increase
200 Samples in 2 Days
High-Res Data Quality

06 — Skills

Technical Competencies

Analytical Technologies

RP-HPLC SEC IEX HILIC LC-MS LC-MS/MS Peptide Mapping Intact Mass qPCR ddPCR ELISA FACS CE-SDS SEC-MALS DSC DLS AUC

Product Categories

Monoclonal Antibodies Bispecific Antibodies ADCs mRNA-LNP AAV Gene Therapy Recombinant Vaccines Viral Vectors

Regulatory & Quality

cGMP ICH Q14 ICH Q2(R2) ICH Q6B ICH Q5E IND BLA MAA ALCOA+ GSP

Leadership & Systems

Team Leadership (10+) CDMO Management ELN (IDBS) LIMS (Labware) AGILE/Scrum Digital Transformation

Independent AI Development

Python RAG Systems LLM Integration Synthetic Data Prompt Engineering

Education & Certifications

PhD Chemistry, University of Toledo (2007) MIT Sloan: AI in Pharma & Biotech (2025)

07 — Publications

Publications

2023

Enrichment of Adeno-Associated Virus Serotype 5 Full Capsids by Anion Exchange Chromatography with Dual Salt Elution Gradients

Lavoie, R.A.; Yearley, E.J. et al. — Biotechnology and Bioengineering 22 citations

2018

Non-Enzymatic and Site-Specific Glycan Shedding: A Novel Protein Degradation Pathway Observed in a Stabilized Form of RSV Prefusion F Protein

Qian, J.; Yearley, E.J. et al. — Analytical Chemistry 18 citations

2014

Observation of Small Cluster Formation in Concentrated Monoclonal Antibody Solutions and Its Implications to Solution Viscosity

Yearley, E.J. et al. — Biophysical Journal 106(8), 1763-1770 215 citations

Featured in:
  • Chemical & Engineering News — "Why Monoclonal Antibody Drugs Get Sticky"
  • Department of Commerce, USA — "NIST Research Offers Guide in Formulating Cancer Treatment Drugs"
  • NIST — "NIST Helps Cancer Treatment Drugs Get Past Their Sticking Point"
  • Scientific Highlight, NIST Center for Neutron Research
  • Scientific Highlight, Institut Laue-Langevin, France
2013

Small-Angle Neutron Scattering Characterization of Monoclonal Antibody Conformations and Interactions at High Concentrations

Yearley, E.J. et al. — Biophysical Journal 130 citations

2011

Shear-Induced Metastable States of End-Grafted Polystyrene

Sasa, L.A.; Yearley, E.J. et al. — Physical Review E 8 citations

2010

The Couette Configuration of the Los Alamos Neutron Science Center Neutron Rheometer for the Investigation of Polymers in the Bulk via Small-Angle Neutron Scattering

Yearley, E.J. et al. — Review of Scientific Instruments 16 citations

2010

The Los Alamos Neutron Science Center Neutron Rheometer in the Cone and Plate Geometry to Examine Tethered Polymers/Polymer Melt Interfaces via Neutron Reflectometry

Sasa, L.A.; Yearley, E.J. et al. — Review of Scientific Instruments 8 citations

2008

Experimental Electron Density Studies of Non-Steroidal Synthetic Estrogens: Diethylstilbestrol and Dienestrol

Yearley, E.J. et al. — Journal of Molecular Structure 44 citations

2007

Binding of Genistein to the Estrogen Receptor Based on an Experimental Electron Density Study

Yearley, E.J. et al. — Journal of the American Chemical Society 87 citations

2007

Electron Density Studies of Selected Nonsteroidal Estrogens

Yearley, E.J. — PhD Dissertation

2007

5-Aminonaphthalene-1-sulfonic Acid and Its Manganese, Nickel and Cobalt Salts

D. J. Genther, E. J. Yearley et al. — Acta Crystallographica 9 citations

2007

2,3,10,11-Tetrathiatricyclo[10.4.0.04,9]hexadeca-4,6,8,12,14,16-hexaene

Yearley, E.J. et al. — Acta Crystallographica 5 citations

08 — Open Source

GitHub Activity

Open source projects and contributions

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Public Repos
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Total Stars
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Followers
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09 — Contact

Let's Connect

I'm always interested in discussing new opportunities in analytical development leadership.

Whether you're looking for expertise in biologics characterization, digital transformation, or building high-performing analytical teams—let's talk.

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Location Durham/Raleigh, NC · Open to Relocation