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Summary

A proactive CMC operations expert with a right-first-time approach and commitment to deliver. Excellent understanding of CMC, drug development, operations, facilitation, commercialisation and project management with over twenty years international experience driving biological projects from research to clinical phases/commercialisation, process optimisation and life-cycle management. Competencies include strong CMC, operations, out-sourcing, project management, life-cycle management, due diligence, RA and QA expertise combined with excellent interpersonal, negotiating skills, project planning, timeline control, financial control and the ability to work well under pressure.   Specialties: Antibody/ biological manufacture, solid, semi-solid, sterile and lyophilised finished products. GMP outsoucing, project management, technology transfer, due diligence support and lifecycle management.

Experiences

Current Experience

  • Head of Chemistry, Manufacture and Control
    Since June 2015
    • Responsible for the implementation and management of global outsourcing CMC strategy for drug substance and drug product manufacture, analytical testing, storage and development • Responsible for driving development operations through late phase drug development ensuring the delivery of a robust, commercially viable GMP processes. • Responsible for resource management, budgeting, forecasting and product supply. • Operational/ strategic management and product launch team member. • Contract negotiations and implementation of supply agreements and master service agreements.

Past Experience

  • Senior Manager Tech Ops/ Global Project Leader
    August 2010 --- June 2015
    • Responsible for strategic and project leadership of a cross functional joint project team (Alcon and ThromboGenics) to execute activities for the registration of a new ready-to-use presentation of Jetrea as part of life cycle management. Key project achievements include: o Defining project scope, project charter and communication planning o Recourse planning, team building and budgetary control o Define US and EU regulatory framework o Coordinate and prepare questions and packs for Scientific Advice for MHRA and FDA o Strategic planning and reporting analytical comparability studies o Finalized risk management plan, medical information plan and commercial launch plan o Oversee EU and US regulatory submission documentation including Modules 1,2 and 3 o Pre-approval inspection and launch manufacturing readiness • Represented CMC and attended Agency meetings. CMC lead in the submissions team for a MAA (under the CeP) and NDA/BLA, now approved by FDA Sept 2012, EMA Mar 2013, SwissMedics Mar 2014, CFDA 2013, UAE 2013 & Uruguay 2014. Multiple RoW submissions currently ongoing. • Regulatory contact for CMC for all regulatory submissions for DS and DP and HA responses. Successfully provides strategic, timely responses to Agency questions. • Responsible for the timely compilation and completion of a variety of CMC submissions, including drafting Agency questions/ responses, INDs, IMPDs, NDAs, Day120, Day180 questions and briefing pack preparation for Scientific Advice (EMA) and Type A & B meetings (FDA). • Responsible for the implementation and management of global outsourcing CMC strategy for drug substance and drug product manufacture, analytical testing, storage, distribution and development ahead of new product launch and commercial manufacture (Jetrea). • Heath Authority inspection readiness and operations. • Contract negotiations and implementation of supply agreements and master service agreements.

  • Technical Project Manager
    November 2007 --- August 2010

  • BioProcess Manager
    August 1990 --- October 2007

Knowledge

LinkedIn Assessment :
Technology transferGMPDrug DevelopmentQuality AssuranceManufacturingBiopharmaceuticalsBiotechnologyFDAValidationPharmaceutical IndustryLifesciencesRegulatory affairsRegulatory submissionsDrug DiscoveryLife SciencesClinical DevelopmentSOPCAPA

Education

  • Great Belt in PMP from Stanwick, Belgium in 2014
  • MSc in Pharmaceutical Medicine from University of Surrey in 2000
  • BSc in Science from University of East London in 1989

Area / Region

Belgium

Others

Driving License
  • No