Dr Jim Mills is a Principal CMC Consultant at GreyRigge Associates (GRA) and a bioprocess expert with nearly 30 years of biopharmaceutical sector experience. Having held CEO and VP-level executive positions at companies including Xenova Research Ltd., Cantab Biopharmaceuticals, and Abzena PLC, he focuses on three strategic areas: conducting technical due diligence and asset technology assessments for company acquisitions; directing early and late-phase bioprocess development (UPS/DSP) across diverse biological modalities; and designing robust CMC product development plans and cGMP compliance manufacturing strategies. Jim holds a PhD in Biochemistry from the University of Leicester, United Kingdom.
Expertise: Primary Service Skillsets
CMC & Manufacturing
Jim brings senior technical operational leadership to complex biological product development programmes across Europe and the USA.
- Bioprocess & Analytical Development: Overseeing upstream (UPS) and downstream (DSP) process design alongside analytical control strategies for prokaryotic and eukaryotic expression systems.
- Quality by Design (QbD) & Facility Layout: Implementing QbD methodologies to establish design spaces and advising on GMP manufacturing facility design for scalable clinical and commercial production.
- Modality Expertise: Guiding process and manufacturing strategies across diverse product types, including recombinant proteins, fusion proteins, monoclonal antibodies, vaccines, live-virus vector ATMPs, live-bacteria therapeutics, and Antibody-Drug Conjugates (ADCs).
Strategic Planning & Due Diligence
Drawing on extensive C-suite experience, Jim evaluates technical risk and aligns manufacturing operations with corporate growth objectives.
- Manufacturing Technical Due Diligence: Conducting comprehensive due diligence, technology assessments, and operational risk evaluations for company acquisitions and asset investments.
- CMC & Manufacturing Strategy: Structuring end-to-end CMC product development plans to accelerate progression from early-phase candidate selection to late-stage commercialisation.
Programme & CDMO Management
His executive leadership ensures seamless technical oversight and alignment across international contract development networks.
- Senior Technical Operations: Directing complex multi-disciplinary teams and managing cross-functional technical workflows across internal sites and external partners.
- Vendor & Network Oversight: Managing CDMO selection, technical governance, and operational execution across international contract development and manufacturing networks.
Additional Technical Specialisms
To ensure comprehensive support across the full development lifecycle, Jim also provides expert consultancy across these core GRA service areas:
- Formulation Development & Stability: Advising on phase-appropriate formulation strategies and stability testing protocols to safeguard complex biologic drug products.
- Assays & Quality Control: Establishing robust analytical testing frameworks, bioassays, and critical quality attribute (CQA) profiles to support batch release.
- QA & Regulatory Affairs: Aligning CMC technical data packages with global regulatory requirements across the FDA, EMA, and MHRA.
If you would like to discuss your project with Dr Jim Mills or require specialist advice, please get in touch.
