Director, Drug Substance

• May 2022 - Present

Principal Scientist

• Feb 2021 - Apr 2022

• Provision of technical consultancy and support of the development of drug/device combination products for the Smith & Nephew Advanced Wound Management business unit. • Coordination of product characterisation and biocompatibility testing activities to ISO 10993. • Completion of risk-benefit literature analyses, to allow strategic planning of R&D activities. • Provision of technical consultancy and support of the development of drug/device combination products for the Smith & Nephew Advanced Wound Management business unit. • Coordination of product characterisation and biocompatibility testing activities to ISO 10993. • Completion of risk-benefit literature analyses, to allow strategic planning of R&D activities.

Technical Transfer Lead

• Sep 2015 - Dec 2020

Responsible for the evaluation, project management and execution of new product introduction and technical transfer activity at site level.• Successfully project managed the introduction of Kisqali® and Votrient® oncology products to Grimsby site, resulting in current annual revenue of $1.5 bn.• Provision of line management of an experienced multi-disciplinary team (chemists, engineers, operational experts) to maximise team performance in a time sensitive environment.

MS&T Product Steward

• Apr 2014 - Sep 2015

Technical responsibility for Galvus® and Entresto® Cardiovascular/Metabolism (CVM) products at site level.• Co-ordination of regulatory relevant business continuity and process improvement initiatives; liaising with suppliers and internal customers (e.g., formulation sites, regulatory affairs).• Effective management of quality issues through facilitation of root cause analyses, CAPA implementation.• Responsible for increasing capacity and productivity of high-profile growing products

Process Manager

• Oct 2007 - Mar 2014

Technical point of contact for multiple processes within a pharmaceutical production building.• Successfully improved Galvus® capacity from 75 mt/year to 175 mt/year by de-bottlenecking process equipment, while ensuring ongoing supply. • Project managed the development of a second generation Galvus® process at Basel R&D site, Switzerland, to eliminate manual handling of a toxic reagent and reduce manufacturing costs.• Included a 9-month International Assignment as a Senior Process Manager in Basel, Switzerland. Show less

Production Shift Chemist

• Feb 2007 - Sep 2007

• Provision of manufacturing technical support within an FDA-audited cGMP custom manufacturing facility on a 24/7 shift basis• Deputised for production shift leader as required

Section Leader - Process Development

• May 2005 - Feb 2007

• Evaluation and co-ordination of custom API manufacturing projects• Provided line management to a team of process development chemists

Senior Chemist - Process Development

• Jan 2001 - May 2005

• Lead Chemist responsible for route selection, process development and scale-up of the syntheses of APIs on behalf of pharmaceutical customers • Manufacture of APIs to cGMP on multi-kilo (20-litre) scale in kilo-lab facility.• Scale-up of chemical processes for manufacture in up to 1600-litre plant equipment.• Production of batch records and related regulatory documentation, supervision of process personnel and presentation of scientific data to a varied audience

Industrial Placement Student

• Mar 1996 - Sep 1996

Student process development chemist in the New Product Introduction (NPI) department of a multi-purpose manufacturing facility. • Developed a modified drying process for an intermediate product of Acrivastine, which improved the efficiency of the subsequent water-sensitive Wittig reaction Student process development chemist in the New Product Introduction (NPI) department of a multi-purpose manufacturing facility. • Developed a modified drying process for an intermediate product of Acrivastine, which improved the efficiency of the subsequent water-sensitive Wittig reaction