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MSAT SMDS EM, Manager
1 month ago
, protocol, report, batch record) upon request. * Evaluate supplier-initiated change initiatives from technical perspective. * Owner of technical section in Account Plan for assigned EMs and engage other MSAT roles at the site to keep corresponding part updated. * Monitor and communicate supplier performance against established metrics.
Develop and follow up improvement plans for supplier performance in collaboration with PES team. * Participate at annual strategy meeting with PES Site Lead and CMO management to discuss long-term strategy for the site. * 10-15 years' experience in a cGMP API manufacturing environment. * Experience in developing/ introducing/scaling-up chemical processes and managing/overseeing commercial production. * Good project management skills in process know-how transfers. * Statistical skills required to perform process data analysis/process modelling/SPC. * Deep understanding of typical unit operations and related process equipment * Trouble-shooting experience/ Affinity with related methodologies. * Must have cross-cultural mindset * Must be highly skilled at collaboration and comfortable working in a matrix organization. DEGREE: * Minimum requirements: University Degree.
Desire MSc or PhD in Chemistry / Chemical Engineering / Biotechnology / Pharmaceutical Science, etc. LANGUAGES: * Fluent in written and spoken English. SPECIFIC SYSTEMS: * SUMMIT * Deviation/Event/Investigation/CAPA Management System (TrackWise or equivalent) * Document Management Systems (Truvault, SharePoint, ...) * Concur * Workday PHYSICAL REQUIREMENTS/WORKING CONDITIONS: * Works in an international environment across different time zones * Frequent travel required * Travel: Min 25% - project dependent
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