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Job ID189143BRPosition TitleSenior Strategy & Technology Leader - Analytics, BiologicsDivisionPHARMABusiness UnitGlobal Tech OpsCountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularJob DescriptionLead and manage a Strategic Process Technology team with the purpose of defining and implementing the “next generation” bioprocess development and manufacturing technologies, within Novartis Biologics.
Apply scientific/technical expertise to drive cross-functional and cross-departmental alignment and further evolve the development of Biopharmaceutical Analytics at Novartis Pharma AG. Develop long term scientific and technology strategies to support the development and application of high productivity, high throughput analytical methodologies.
• Responsible to lead a sub-team charged with developing disruptive technologies and designing a strategic paradigm shift in the development of biologic analytical methodologies and strategies, to enable fastest delivery to the market.
• Set strategic priorities for the functional sub-team, aligned to deliver the overall global strategic initiative goals
• Lead a program to set the direction and foundation for all future analytical development activities within Biologics Technical Development & Manufacturing (BTDM).
• As a core team member of a global strategic initiative; develop strategies, novel technologies and drug substance manufacturing processes for the clinic and commercial production.
• Ensure the alignment of cross-departmental functions to ensure global implementation, including integration with drug product processes.
• Indirect management and mentoring of several associates and function leaders.
• Understand resource constraints and identify/lead cost saving opportunities.
• Support technology evaluations and proactively identify/realize opportunities for Intellectual Property in the product portfolio and technology projects.
• Timeliness of project deliverables
• Customer satisfaction
• Quality of proposed concepts and strategies
• Quality of plans and documents
• Efficiency of communication internally and externally
• Resource efficiencyMinimum requirementsPhD or equivalent education in Biology, Biochemistry, Chemistry, Chemical Engineering or a related discipline
Fluent English required (oral & written); good skills in German as local site language (oral), desired
•At least 10 years of experience in the development of analytical methods and control methodologies for biopharmaceuticals (DS & DP development & manufacturing process); experience in late phase development and commercialization is highly desirable.
•Hands-on experience analytical method design and regulatory implementation for biopharmaceuticals is required.
Previous experience with integration of new technologies and process analytical technologies (PAT) into a manufacturing and/or Quality environment is advantageous. •Good knowledge of analytical method validation and instrument qualification for physico-chemical and bioanalytical methods •Broad experience with molecular characterization is preferred.
•Experience in filings with health authorities, preferably with BLAs/MAAs