As Senior Method Expert you will be part of the Method Expert Team of Process Analytical Sciences at our TRD Biologics site in Basel.Your responsibilities include, but are not limited to:
Method Development and Optimization using Quality-by-Design (QbD) Principles: Applying QbD principles, drive and execute the physicochemical analytical (PCA) method development and optimization of assigned pipeline projects for all relevant sample matrices (Drug Substance, Drug Product, Intermediates). Design experiments, perform risk assessments, and utilize statistical tools to develop robust and reliable analytical methods. Method trending: Ensure appropriate trending of method performance parameters by establishing trend/control charts for relevant methods. Advanced Instrumentation and Technology: Leverage advanced analytical instrumentation and emerging technologies to enhance existing analytical methods. Miniaturization and Automation: Explore opportunities for miniaturization and automation to increase throughput, reduce sample and reagent consumption, and enhance efficiency. Implement automated platforms to streamline method development. Data-Driven Approaches: Utilize data analytics, machine learning and modelling approaches for method development. Identify correlations between product quality attributes and method parameters to optimize method performance. Regulatory Compliance: Ensure compliance with regulatory requirements and support filings applying principles described in recent guidelines for analytical method development (e.g. ICH Q2(R2) and Q14). Stay updated on evolving regulatory expectations e.g. related to validation strategies. Collaboration and Leadership: Collaborate with cross-functional teams, including research, DS & DP process development, quality assurance, and regulatory affairs, to align method development activities with organizational goals and project timelines. Provide technical leadership, guidance, and mentorship to junior team members.
• University degree (PhD or equivalent is desirable) in life sciences• Minimum of 10 years of proven relevant experience in the pharmaceutical industry
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
