Amsterdam, North Holland, Netherlands
Experienced Qualified Person and PhD-qualified Organic Chemist with a strong track record across process development, CMO oversight, and commercial Quality Assurance within the global pharmaceutical industry. Currently at Rhythm Pharmaceuticals, supporting GMP compliance and oversight of commercial manufacturing and supply across the full product lifecycle, from drug substance and drug product through to packaging and distribution. Brings extensive experience working with global CMOs and cross-functional teams across Europe, the US, and Japan, leading technology transfers and driving quality activities in complex, regulated environments. Strong contributor to regulatory submissions, inspections, and the continuous improvement of Quality Management Systems. Known for a pragmatic, risk-based approach and the ability to balance compliance with business needs while ensuring uninterrupted supply to patients. Passionate about delivering high-quality medicines and building robust, efficient quality systems within dynamic, international organisations.
Senior Manager, Batch Release Coordinator & QP
• Leading day to day activities to ensure that the projects are on time, on budget and within scope • Co-accountable for providing scientific and technical support to ensure the regulatory submission requirements are met • Effectively communicate with key-stakeholders on the project progress and highlight any potential risks • Responsible for drug substance, drug product and analytical method validation • Providing support for batch release activities and working closely with RP and QP • As a qualified auditor responsible for conducting internal and external audits
o Responsible for providing experimental and technical work packages for a late phase project to support FDA filing o In charge of document review, process familiarisation and stretching to enable technical transfer to third party supplier o Independent author and contributor to internal documentation such as reports, memoranda and presentations. o Responsible for maintaining a safe working environment in the highly-restricted area of the antibiotic laboratory and training others to prevent cross-contamination (member of safety committee, govern the Team site on regular basis). o Co-responsible for decommissioning activities of antibiotic laboratory – co-author of decontamination protocols, liaising with Q&A and external contractors to ensure timely delivery of this project. o A member of High Throughput Chemistry (HTC) design team to support formation of smartlab – collaboration with architects, engineers and scientists across the PDS platform.
o Lead chemist for the development of a new Ru-catalysed method that allows a rapid generation of α-arylated benzoic acids. o Co-organised and chaired PhD presentations and the scientific poster session at Postgraduate Conference at Manchester University (9-10 Jun 2016). Involved in training undergraduate, MChem and doctoral students. Organised and attended weekly group meetings and brainstorming sessions. o Appointed a safety representative of my research group to support smooth and effective running of the laboratory.
o Successfully identified and led demonstration of a route for the synthesis of highly functionalized spirocyclic compounds. This project required working under pressure and short deadline due to significant competition in this field from other research groups. o Author and contributor of scientific papers and academic reports. Presented work at a number of conferences nationally and internationally.
Laboratory demonstrator for 2nd year undergraduate chemists