Analytical methods development
Designing, qualifying and transferring robust, phase-appropriate analytical methods.
About
Senior analytical CMC expertise, brought directly to your programme.
Elementary CMC Consulting is led by Laura Sherlock — an analytical CMC & QC leader with more than two decades in biologics and advanced therapeutics.
LauraFounder & Principal Consultant
Laura Sherlock
Analytical CMC & QC leader for biologics.
Laura is an analytical CMC leader with 20+ years of experience bringing complex biologics and advanced therapeutics from early development through late-stage clinical and commercial. Her work spans novel modalities, analytical strategy, IND/BLA/MAA readiness and CDMO oversight across biologics and cell therapy.
She has provided analytical CMC and QC leadership for a late-stage monoclonal antibody programme approaching BLA submission, and built the analytical framework for a first-in-class gene-edited cell therapy. Her core strengths are analytical methods development, CDMO management, analytical control strategy and CMC leadership.
Track record
A career across biologics and advanced therapeutics.
2026 — Present
Director
Elementary CMC Consulting
Specialist analytical CMC & QC consultancy for biologics, cell & gene therapy and novel modalities.
2025 — 2026
Analytical Consultant
Cidara Therapeutics
Analytical CMC consulting support for a biologics development programme.
2024 — 2025
Analytical Development & QC Consultant
Prothena Corporation
Analytical CMC and QC leadership for a late-stage monoclonal antibody programme approaching BLA submission.
2022 — 2024
Director, Analytical Development & QC
bit.bio
Analytical CMC lead — built the analytical framework for a first-in-class gene-edited cell therapy.
Earlier
Senior CMC & QC roles
Jazz Pharmaceuticals · Pfizer · Trinity Biotech
Two decades of progressive analytical development, quality control and project leadership across pharma and biotech.
Core expertise
Where Laura adds the most value.
Analytical control strategy
Specifications, comparability and control strategies that hold up to regulatory scrutiny.
CDMO management & CMC leadership
Leading cross-functional teams and overseeing outsourced analytical work end to end.
Educated at Dublin City University, Laura combines deep analytical science with the strategic perspective needed to move complex programmes toward the clinic and the market.
Bring senior CMC expertise to your team.
From early development to commercial filing, Laura works as an embedded leader or a focused expert advisor.