Samantha Dowse is a Director, Managing Partner, and Principal Consultant at GreyRigge Associates (GRA). She focuses on three critical technical areas: designing robust analytical characterisation strategies, leading seamless cross-border technology transfers, and applying advanced statistical methodologies to accelerate product development. With over 20 years of biopharmaceutical industry experience across major global organisations; including GlaxoSmithKline (GSK), Ipsen Biopharma, Lonza, and Emergent BioSolutions, Samantha bridges the gap between complex analytical science, regulatory expectations, and operational project execution.
Expertise: Primary Service Skillsets
Assays & QC Validation
Samantha possesses deep, practical expertise in the design, validation, and trouble-shooting of complex analytical methods for biopharmaceutical characterisation. Her approach focuses on building robust quality architectures that ensure long-term product comparability and stability.
- Method Development & Validation: Directing end-to-end analytical assay development, qualification, and validation under strict GxP and international regulatory frameworks.
- Statistical Design: Applying advanced statistical methodologies (including Design of Experiments / DoE) to establish robust design spaces, method capability, and reliable analytical specifications.
- Stability Study Architecture: Designing, managing, and interpreting complex stability programmes to support shelf-life extension and clinical progression.
CDMO & CRO Network Management
Her technical leadership extends to managing outsourced relationships, ensuring that external partners deliver technical precision and remain aligned with commercial timelines.
- Technology Transfer: Directing complex technical transfers of analytical assays and manufacturing processes between internal R&D sites, CMOs, and CDMOs.
- Vendor Oversight: Negotiating, auditing, and managing technical contracts, quality agreements, and operational deliverables across an extensive international vendor network.
QA, Auditing & Regulatory Affairs
Samantha translates complex analytical datasets into clear, approvable regulatory documentation that satisfies the evolving compliance requirements of global governing bodies.
- Dossier Preparation & Submissions: Authoring and reviewing analytical and CMC documentation for regulatory filings, including clinical trial applications, INDs, and BLAs.
- Regulatory Compliance: Ensuring analytical method alignment with FDA, EMA, and MHRA guidelines, supporting client scientific advice briefing packages and regulatory responses.
Additional Technical Specialisms
To ensure comprehensive support across the full development lifecycle, Samantha also provides expert consultancy across these core GRA service areas:
- CMC Project Management: Leading both internal and outsourced cross-functional project teams to maintain forward momentum, manage operational risk, and hit key clinical milestones.
- Tailored Technical Problem Solving: Delivering bespoke analytical troubleshooting and root-cause analysis for out-of-specification (OOS) investigations and process comparability studies.
- Cross-Functional Leadership: Embedding structured project governance across multidisciplinary teams spanning R&D, Quality Control, Regulatory Affairs, and commercial manufacturing.
If you would like to discuss your project with Samantha Dowse or require specialist advice, please get in touch.
