John Little is a Senior CMC Consultant at GreyRigge Associates (GRA) and a scientific leader with extensive experience across the biopharmaceutical and gene therapy sectors. Spanning roles in academia, the public sector, commercial industry, and independent consultancy, John focuses on three core strategic areas: advancing viral vectors and cell & gene therapy (CGT) assets; designing comprehensive analytical control and testing strategies; and leading regulatory strategy and agency interactions across global competent authorities.
Expertise: Primary Service Skillsets
CMC & Manufacturing
John brings deep scientific leadership to early and late-stage bioprocess development, with specialised capability in advanced therapy medicinal products (ATMPs).
- Gene Therapy & Viral Vectors: Guiding the development, scale-up, and characterisation of viral vector systems for gene transfer and advanced cell therapies.
- Process & Product Control Strategies: Designing integrated testing frameworks to establish critical quality attributes (CQAs) across upstream, downstream, and fill-finish workflows.
- Pre-clinical & Clinical Development: Translating complex laboratory datasets into phase-appropriate clinical manufacturing and testing strategies.
Assays & Quality Control
His analytical background underpins deep technical expertise in establishing, validating, and troubleshooting complex analytical workflows for novel modalities.
- Analytical Sciences & Characterisation: Directing quality control, biochemistry, cell-based potency bioassays, immunodiagnostics, biomarkers, and bioanalysis.
- Nucleic Acid Technologies: Expertise in advanced molecular characterisation and nucleic acid testing strategies (PCR, sequencing, purity assays) for viral vectors and biopharmaceuticals.
QA, Auditing & Regulatory Affairs
John translates technical data into clear, approvable regulatory documentation for global regulatory bodies.
- Regulatory Dossier Authoring: Authoring and reviewing CTD Modules 2, 3, and 4 for regulatory submissions globally.
- Competent Authority Interactions: Leading scientific advice meetings and formal discussions with regulatory authorities, including the MHRA, EMA, and FDA (CBER/CDRH).
- Compliance Standards: Ensuring strict alignment with cGMP, GLP, GCP, and ICH guidelines.
Additional Technical Specialisms
To ensure comprehensive support across the full development lifecycle, John also provides expert consultancy across these core GRA service areas:
- Programme & CDMO Management: Managing external laboratory workflows, vendor selection, and technical oversight across contract development partners.
- Formulation Development & Stability: Advising on stability testing protocols, comparability assessments, and formulation strategies for viral vector and biopharmaceutical assets.
- Strategic Planning & Due Diligence: Evaluating analytical validation packages, CMC readiness, and regulatory risk for investors and drug developers.
If you would like to discuss your project with John Little or require specialist advice, please get in touch.
