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Job ID 210961BR Position Title Process Development Expert Division Global Drug Development Business Unit TECHNICAL R & D GDD Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description The Process Development Expert will lead and manage process development activities related to filling and spray-drying of inhalation powders. The successfull candidate will apply scientific/technical expertise to address complex R&D issues for the preparation and timely delivery of inhaled drug products (DP), scale-up spray drying processes and procedures; coach team members, participate in teams and contribute to overall Technical R&D (TRD) strategies and goals.
Major Accountabilities include:
- Contributing to project strategy, by demonstrating full accountability for all spray drying process scale-up for assigned inhalation projects.
- Ensuring these are fully aligned and integrated in project development plans.
- Contributing to risk analyses and/or peer review & process challenge meetings.
- Driving the execution of development activities following sound scientific rational for all planned experiments.
- Designing, planning, performing and monitoring all assigned activities related to the development of filling and spray drying processes and their scale up.
- Identifying critical process parameters and fully evaluating their impact on quality.
- Ensuring processes delivered are optimized and robust.
- Interpreting results, evaluating data, drawing relevant conclusions and writing reports to support the definition of process conditions and boundaries, plant fit of processes including all quality by design documentation.
- Ensuring timely and accurate preparation, review and approval of all required documentation, e.g. lab procedure, master batch record MBR, QbD and QRA documents
- Closely collaborating and exchanging with development units, production units and external contract organizations for the transfer and scale up of filling and spray drying processes. Minimum requirements Education:
- Bachelor with a PhD in chemistry or engineering related to spray drying
- Fluent in English
- at least 5 years experience working as a process expert on spray drying development