Dr Rod O’Keeffe is a Senior CMC Consultant at GreyRigge Associates (GRA) and a senior biopharmaceutical expert with extensive experience in the development, characterisation, and manufacturing of complex biological products. He focuses on three critical strategic areas: designing phase-appropriate bioprocess and formulation architectures, executing seamless international technology transfers, and authoring robust regulatory CMC documentation for global agency submissions. Rod holds a PhD from Aston University, United Kingdom.
Expertise: Primary Service Skillsets
CMC & Manufacturing Oversight
Rod possesses deep practical expertise across the technical design, scale-up, and cGMP manufacturing of diverse biopharmaceutical modalities. His hands-on skillset focuses on embedding scalable, science-driven frameworks into active development pipelines.
- Process & Formulation Development: Designing robust upstream and downstream bioprocesses alongside phase-appropriate formulation strategies to enhance product stability and delivery.
- cGMP Manufacturing: Directing operational scale-up, facility fit reviews, and cGMP compliance protocols from early-stage clinical trial supply through to commercial readiness.
- Biological Characterisation: Applying advanced analytical and structural characterisation techniques to establish product comparability, purity, and critical quality attributes (CQAs).
CDMO & CRO Network Management
His technical leadership extends to managing outsourced development relationships, ensuring external partners maintain technical precision and adhere to project timelines.
- Process Technology Transfer: Directing complex technology transfers of bioprocesses, analytical methods, and manufacturing protocols between internal sites and external CDMOs.
- Vendor Oversight: Managing technical interactions, operational delivery, and Quality Technical Agreements (QTAs) across international CDMO networks.
QA, Auditing & Regulatory Affairs
Rod translates complex laboratory and manufacturing datasets into clear, approvable regulatory documentation that meets the compliance thresholds of global governing bodies.
- Dossier Preparation & Submissions: Authoring and reviewing regulatory CMC documentation (Module 3) for clinical trial applications and commercial registrations globally.
- Agency Compliance: Aligning technical and manufacturing data packages with FDA, EMA, and MHRA guidelines to support successful agency reviews and approvals.
Additional Technical Specialisms
To ensure comprehensive support across the full development lifecycle, Rod also provides expert consultancy across these core GRA service areas:
- Analytical Method Validation: Overseeing phase-appropriate validation of analytical procedures in line with ICH guidelines to support batch release and stability testing.
- Risk & Comparability Management: Conducting technical risk assessments and comparability protocols during process changes or manufacturing site transitions.
- Clinical Project Management: Leading cross-functional technical teams to maintain operational momentum, mitigate risk, and achieve key development milestones.
If you would like to discuss your project with Dr Rod O’Keeffe or require specialist advice, please get in touch.
