Analytical LCM Portfolio Lead

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Job Description While a primary location is identified for this role, qualified internal candidates in Zurich, Linz, Dublin, Vienna, Hikari may also be considered, subject to business needs, role requirements, talent availability, and local legal requirements.

About the role:

Owns and drives Analytical LCM Portfolio Standardization & Governance across modalities related to analytical commercial control strategies (methods and specs) to drive consistent and scientifically-sound decision making, including establishing and maintaining RACI and processes.

Portfolio Analytical Oversight:
Ensures analytical LCM method risk registers are standardized, created and maintained across the portfolio and network. Monitor risk registers in collaboration with analytical program leads to develop Analytical LCM roadmaps and strategies to address methods at-risk. In collaboration with Analytical LCM Modality Leads, provide functional leadership for all Analytical LCM Program representatives, ensuring consistent scientific direction, portfolio prioritization, capability building, and clear accountability for program deliverables.

Oversee Analytical LCM Portfolio resourcing management:
Set and executes the enterprise Analytical resourcing strategy and prioritizes analytical portfolio needs across internal and external labs in collaboration with analytical program leads and laboratory scientists.

Strategic interface with key stakeholders on cross-modality portfolio planning of new CMC processes, analytical development technical and product strategies, roadmaps & initiatives. Embed AQbD and risk-based thinking in method development, qualification/validation, and lifecycle management to improve robustness, reduce investigations, and accelerate tech transfer and comparability.

How you will contribute:

Define, maintain, and communicate the global Analytical LCM Portfolio Strategy, including CMC processes, roadmaps and initiatives aligned to pipeline needs.

Own the standardized approach for portfolio analytical LCM strategies (method capabilities, specifications, comparability), ensuring consistency across modalities and network and consistent scientific decision-making. Coordination with Pharm Sci & BD on integration of incoming portfolio program analytical strategies are consistently pulled through into commercial lifecycle management.

Establish and drive Analytical LCM Portfolio Standardization & Governance across modalities related to analytical commercial control strategies (methods and specs) to drive consistent and scientifically-sound decision making in collaboration with GSQ and Pharm Sci, including establishing and maintaining RACI and processes. Ensure analytical governance and quality oversight across the network, including standards, training, and inspection readiness expectations for data integrity and documentation practices.

Establish analytical LCM roadmap standards, templates, and governance for method development and validation/verification (including robustness and risk assessments) to ensure fit-for-purpose methods and right-first-time transferability.

Oversee analytical LCM resourcing prioritization of work by assessing within the organization and prioritizing internal versus external work.

Build and maintain organizational capability on method risk registers to monitor method performance and proactively implement measures to ensure products and methods…