Sabine Thielges

Visionary and results-driven manager with a Ph.D. and MBA (candidate), offering deep expertise in digital innovation, chemistry, and pharmaceutical development. Adept at leading global digital transformation initiatives across CMC functions, integrating AI and data science to accelerate product development, enhance regulatory readiness, and optimize operational efficiency. Proven track record in building high-performing teams, fostering cross-functional collaboration, and delivering strategic solutions that align with business and regulatory goals.

Leverages agile planning methodology that enables state-of-the-art and data-driven strategies such as Accelerated Predictive Stability (APS) to speed product development, while reducing costs, and increasing product knowledge or utilize AI / data science in co-development with MSFT that empower scientists. Collaborative leader and team contributor with expertise in coaching, directing, and mentoring diverse, cross-functional teams to execute with a high sense of priority / urgency.

Director Digital innovation lead CMC at NOVARTIS PHARMA (2023-01 – Present)

Led organizational transformation that optimized efficiency, planning, and delivering the products globally and ensured operational discipline and GxP / HSE adherence, moving the team to a trusted delivery partner with excellent KPI's in delivery, data integrity, and quality.

• Leading the creation of a transformative process through the Digital and AI Excellence team, introducing a new way of working that delivered substantial business value—cutting manual steps by 80%, accelerating cycle times, boosting efficiency, and enhancing data-driven decision-making
• Design, Develop and manage digital and data science portfolios, including model development and solution scoping.
• Spearhead change management, training, and communication strategies to drive digital adoption through a user centric approach.
• Define framework for an optimized "ideas to implementation" journey by focusing on user journeys and process flows to optimize platform usability and engagement, using applying agile methodologies.

Director / Team Head, Analytical R / D at NOVARTIS PHARMA (2022-01 – 2023-12)

Led organizational transformation that optimized efficiency, planning, and delivering the products globally and ensured operational discipline and GxP / HSE adherence, moving the team to a trusted delivery partner with excellent KPI's in delivery, data integrity, and quality.

• Oversaw a team of analysts, a project leader, and compliance experts, 15 associates, who specialized in aseptic drug product development and GMP manufacturing support.
• Drove the strategy and managed the budget of the team to adapt and evolve to better support the NVS portfolio.
• Ensured and monitored team performance, robust resource planning, and operational excellence. Reduced overdue, delay and misses to zero improving all team KPI above monitoring level.
• Supported site decommissioning, from instrument retirement, and transfer, to associate announcement and support. Finalizing exit three months ahead of schedule and within <80% of budget.

Project Leader, Data / Digital at NOVARTIS PHARMA (2019-01 – 2023-12)

Led cross-functional data science projects and co-developed a novel research platform in collaboration with Microsoft.

• Interfaced with a platform architect and data engineer for URS implementation, and data modeling development using FAIR principal, allowing to build a real citizen data scientist platform.
• Defined user journey and process flow for the platform end user with a user-centric approach increasing adoption by 50% compared to previous solution.
• Managed model and data science portfolio in Research Canvas to bring app/digital journey to all associates.
• Spearheaded data / digital change management, communication, and training, improving adoption of solution.

Analytical Project Leader - Stability and APS expert at NOVARTIS PHARMA (2016-01 – 2019-12)

Championed multiple early-phase analytical projects in a matrix environment for drug substances and parenteral drug products. Built and led a team of experts that supported all development projects.

• Developed and managed analytical strategies, resources, specifications, and methods.
• Wrote and reviewed relevant technical documents.
• Supported analytical strategy for early phase filling including IND / IMPD, bringing seven projects to the clinic.
• Served as the Stability Expert, fully implemented APS across Novartis from vision to use in every product development, reducing development time by 3 to 6 months, while reducing costs, and increasing product knowledge.
• Supported and reviewed stability design, followed up and reported for drug substance and drug product oral and parenteral in early and late phase, ensuring alignment of SOP with latest guidelines.
• Co-led EFPIA and acted as a member of IQ risk-based predictive stability groups that furthered establish the APS approach in the industry and regulatory landscape.

Team Lead | Stability Expert at JANSSEN PHARMACEUTICA (2012-01 – 2016-12)

Developed and implemented predictive models and quality by design (QbD) approaches to understand in depth the chemical and physical basis of drug product degradation. Managed and mentored a team of analysts and scientists, organized regular scientific training sessions and presentations with eight direct reports.

• Implement end-to-end Accelerated Stability Assessment Protocol (ASAP) and acted as SME.
• Successfully delivered first phase I filling with only APS data, speeding the phase I development by ~3 months.
• Partnered with regulatory guidelines and authorities, wrote scientific reports and assessments that supported filings, and CSU in answering authorities' questions regarding stability and excursion.
• Project-managed stability study design followed up and reported for development and regulatory filling.
• Operated under GMP regulation.

Research Associate, Dr. Konishi at NRC (2008-01 – 2011-12)

Monitored Homology modeling of Dopamine D2 / D4 receptors and QSAR study of lead antiangiogenic compounds and synthesis of lead compounds. Co-supervised a Ph.D., and master's students, and an analytical technician.

• Developed LC-MS / MS methods and eye drop formulation using a Design of Experiment (DOE) study of excipients compatibility
• Developed and implemented procedures and utilized a common database for protocols and scientific reports.

Postdoctoral Fellow, Professor N. Moitessier | Professor G. at MCGILL UNIVERSITY (2005-01 – 2008-12)

Master of Business Administration in Pharmaceutical Industry Management – Cambridge Corporate University

Doctor of Philosophy in Organic Chemistry – Haute Alsace University

Master of Science in Molecular Chemistry | Physical Chemistry – H. Poincare University