Mark Pickering Email & Phone Number

A CMC and QA professional with over 30 years of experience within pharmaceutical development and commercial environments. Extensive experience and a comprehensive technical understanding of both API and drug product development, including small molecules, biologics and more recently oligonucleotides (siRNAs). Hands on experience in writing Quality Sections of IMPD/IND Module 3 and related discussions with EU and FDA regulatory authorities. A successful track record of achievement and delivery in the following key areas:Extensive knowledge and experience in CMC development and strategy for small molecules and oligonucleotides (siRNAs).Planning, managing and fronting GMP regulatory authority inspections.Preparation of CMC dossiers and modules for EU (IMPD and MAA) and US (IND and NDA/ BLA) submission. Technical understanding and written interpretation of manufacture and analysis for APIs (small molecules, biologics and siRNAs) and drug products (solid oral dose and sterile /aseptic filled products).Leading complex CMC and combination product projects through clinical development.Interfacing extensively with regulatory authorities in Europe and US as a subject matter expert for small molecules and oligonucleotide manufacturing and analysis.Sponsor oversight and project management of CDMOs.Engagement and negotiation with FDA, MHRA and EU authorities during facility pre-approval inspections, CTA/IND submissions and scientific advice meetings.CMC and inspection readiness gap analysis and remediation action plans.GMP facility pre-approval and due diligence audits on behalf of sponsor/ client.

Listed skills include Gmp, Fda, Quality Assurance, Validation, and 14 others.