Technical & Regulatory Experience

Jon’s experience includes monoclonal antibodies, recombinant proteins, viral vectors, advanced therapy medicinal products (ATMPs), and live attenuated viral vaccines. He has supported programmes from early development through clinical manufacturing and regulatory submission readiness.

He has extensive interaction experience with global regulatory authorities including MHRA, FDA, PMDA, TGA and ANVISA. His expertise spans Quality Assurance leadership, validation and qualification of facilities and equipment, analytical and process interfaces, GMP training and compliance oversight.

Industry Contribution

Jon is an experienced speaker at international industry conferences including ISPE, contributing to best practice discussions across pharmaceutical manufacturing, quality systems and regulatory alignment.

He is recognised for a pragmatic, solution-focused approach and his ability to align cross-functional stakeholders around clear, defensible development strategies.

How I Work

My approach is pragmatic, structured and outcome-focused. I work alongside leadership and cross-functional teams to clarify risk, align strategy and establish defensible quality and manufacturing decisions.

Engagements typically begin with an independent assessment of programme status, regulatory positioning and operational readiness. From there, I support teams in defining clear priorities, reducing uncertainty and implementing practical actions that strengthen compliance and delivery confidence.

I operate as a collaborative partner — comfortable navigating complexity, challenging assumptions constructively and maintaining focus on what is commercially and regulatorily defensible.

My objective remains consistent: provide clear, defensible strategic guidance that enables confident progression through regulatory and manufacturing milestones.

Typical Engagement

• Initial diagnostic review — Independent assessment of programme status, regulatory positioning and manufacturing readiness.
• Risk prioritisation — Identification of critical quality, compliance and CMC risks impacting delivery timelines.
• Strategic alignment — Working with leadership and technical teams to define clear, defensible development pathways.
• Targeted implementation support — Focused input across remediation, inspection readiness, tech transfer or development planning activities.

Who I Typically Work With

• Biotech leadership teams preparing for clinical progression or regulatory interaction
• Organisations strengthening quality systems within GMP manufacturing environments
• Advanced therapy and biologics programmes navigating complex CMC development
• Companies requiring independent oversight or strategic challenge during critical milestones