Analytical Dev&Innovation Biochemistry Lab Manager

Vor 2 Tagen

CorsiersurVevey, Schweiz Merck KGaA, Darmstadt, Germany Vollzeit

In the "Analytical Dev. and Innovation" organization of Global Analytical Development, this role represents an opportunity to significantly contribute to the startup of high-tech analytical laboratories in the BDC, and will give you direct management responsibility over a team of analytical experts and technicians involved in the development and automatization of analytical methods, to ensure the delivery of our specialty innovator Biotech pipeline to patients. Your key responsibilities in this role are:Manage the high-tech analytical development laboratories in the BDC and related documentation; oversee analytical processes and support the scientific strategyLead the "Analytical Dev. and Innovation" biochemistry Lab to conduct early phase development and automatization of analytical methods and ensure high throughput support to process development of NBEs and ADCsManage, develop, coordinate and engage laboratory staff, including training program, performance management, and development plans Target the lab focus on Safety, Quality, Service, Efficiency, People as well as on automated and digital technologiesResponsible for laboratory planning, coordination and performance monitoringProvide analytical innovation competence and technology, including support to novel process analytical technologies approaches, so that all analytical activities are executed with state of the art technologies, comply with the Quality Management System and meet regulatory expectationsInteract and collaborate with all the other CMC functions and sites in the technical development team for the assigned projectsInteract with auditors in the context of internal audits and external inspections by HAsRaise and manage any risk/issues on critical path to CMC development team and analytical technical functions, and propose continuous improvement for processes and technologies Who you are: Graduate degree or Ph.D in Chemistry, Pharmacy, Biology, or Biotechnology with an emphasis on Protein Analytical Chemistry5+ years hands-on experience in but not limited to biochemistry methods (e.g., Immunoassay, Optical density, digital PCR, Capillary Electrophoresis), with 2+ years previous laboratory management experience Good understanding of USP and DSP process in the frame of biopharmaceuticals developmentKnowledge on international guidelines (e.g. ICH) for biopharmaceuticals; knowledge of Data generation, Data processing, Data Quality principles, Quality by Design (e.g., DoE)Hands-on experience with automation technologies, digital tools and lean principlesCuriosity and open minded to new tools & technology, with change management mindset to influence team future ways of workingCommunication skills to inspire and motivate team / relationship management, with ability to interact in stakeholder networks, with proven collaborative attitudeLeadership skills with people development orientation; problem solving, focus on executionEnglish fluent, French is a plus

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