Laura is an analytical CMC consultant with over 18 years' experience in biopharma, specialising in guiding programmes through phase-appropriate analytical development toward IND, BLA and MAA readiness. She has particular strength in resolving complex technical and assay issues, de-risking tech transfers and setting robust specifications, with extensive experience managing CDMO and CRO oversight across a broad range of modalities. Laura provides expert technical leadership to ensure GMP compliance and delivery of high-quality analytical data packages that support successful global regulatory submissions.
Expertise: Primary Service Skillsets
CMC & Analytical Development
- Method development, qualification and validation, in line with ICH Q2(R2) and Q14
- Specification setting and phase-appropriate testing strategies
- Stability programme design to support development and regulatory milestones
CDMO & CRO Oversight and Programme Management
- Technical leadership and project management of external testing and manufacturing partners
- Outsourcing contract negotiation, budget and timeline management
- Cross-functional CMC leadership within matrixed organisations
Regulatory Submissions Management
- Preparation of technical reports and submission documents, including BLA, IND and IMPD
- GMP compliance and technical CMC transfers between sites and CDMOs
- Team leadership, mentoring and departmental performance management
Additional Technical Specialisms
- Assay & Quality Control: Chromatographic, electrophoretic, ELISA and cell-based assay expertise supporting release and characterisation testing.
- Formulation Development & Stability: Designing and overseeing stability programmes to underpin development and regulatory milestones.
- Preclinical & Non-Clinical Support: Analytical strategy for pre-clinical dossiers and agency interactions across novel modalities.
- Cell & Gene Therapy Analytics: Analytical strategy across the iPSC/gene-edited cell therapy production lifecycle, from Master Cell Bank through to release testing.
- Complex Modality Experience: Monoclonal antibodies, Fc drug conjugates, conjugated vaccines and cell therapies.
To understand more of Laura's background and experience, click here.
If you would like to discuss your project with Laura Sherlock or require specialist advice please get in touch.
