Global Technical Leader for sterile biotech products at Chiesi ensuring technical robustness throughout product lifecycle. Leading industrialization strategy and lifecycle management projects in a collaborative environment.
Responsibilities
act as the global technical reference for sterile biotech products
ensure technical robustness throughout the product lifecycle
deliver innovative, compliant solutions supporting the business and Quality organization
contribute to the definition and execution of the industrialization strategy for new products within the R&D Product Teams
structure, plan, and coordinate industrial process validation activities
provide technical leadership for lifecycle management projects concerning established products
oversee the technical assessment and implementation of modifications to critical components
lead and oversee Technology Transfer activities from R&D or external partners
coordinate Product Technical Teams and/or contribute to cross-functional workstreams
review and approve technical protocols and reports
support Program Managers in preparation of key deliverables and updates for governance bodies
collaborate with Virtual Plant Managers and Procurement
perform product Sustainability Assessments and define improvement plans
Requirements
Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field
10+ pharmaceutical/biotech industry years in drug product manufacturing
experience in aseptic processing
fluency in written and verbal communication in English
willingness to travel up to 30%
experience working in multicultural and multinational environments preferred
experience working within a CRO or CMO environment preferred
demonstrated strength in project management, problem-solving, and interpersonal communication
solid understanding of the pharmaceutical industry and end-to-end Biotech sterile products manufacturing
experience in pharmaceutical or biotech MSAT process development and/or GMP manufacturing preferred
strong working knowledge of current regulations, quality expectations, and industry trends
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