Mark Pickering

Background

About Mark Pickering

A business orientated CMC and Quality Assurance freelance consultant with 30 years of experience within pharmaceutical development and commercial environments. Having gained a comprehensive technical understanding of small molecule and oligonucleotide manufacture and analysis for both drug substance and drug product (solid oral dose and sterile fill finish). A successful track record of achievement and delivery in the following key areas: • Extensive knowledge and experience in project management, quality assurance and regulatory CMC for oligonucleotide (siRNA) clinical development. • Strategic development and preparation of CMC dossiers and modules for EU (IMPD and MAA) and US (IND and NDA/ BLA) submission. • Engagement and negotiation with FDA, MHRA and EU authorities during facility pre-approval inspections, CTA/IND submissions and scientific advice meetings. • Performing GMP facility pre-approval and due diligence audits on behalf of sponsor/ client. • Design, implementation and management of GMP QA systems, fulfilling FDA and MHRA inspection requirements. • Planning, managing and fronting GMP regulatory authority inspections. • Inspection readiness gap analysis and remediation action plans. • CMC, QA and regulatory support for clinical development of small, biological and siRNA molecules. Sponsor oversight and project management of CMOs.