Analytical LCM Portfolio Lead

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 remain in control for the lifetime of use.
• Partner with QA, QC, Manufacturing/MSAT, Regulatory CMC, Supply Chain, Pharm Sci, and IT to ensure submission-ready analytical sections, inspection readiness, and governance for change control and lifecycle management.
• Drive Analytical LCM Portfolio Excellence (ways of working, knowledge management, metrics, and continuous improvement) to improve throughput, compliance, and quality outcomes.

Minimum Requirements/Qualifications

• Education: BS/MS in Chemistry, Pharmaceutical Sciences, or related discipline (PhD preferred).
• Experience: 12+ years in pharma/biotech with depth in Analytical Development and/or QC, including significant people and matrix leadership and accountability for strategy, governance, and delivery across multiple programs including NDA or BLA filings.
• Control strategy & filings: Demonstrated experience developing analytical control strategies, holistic control strategies and supporting regulatory submissions (IND/IMPD/BLA/NDA/MAA), including specifications/justifications, stability, and comparability strategies.
• AQbD / validation & lifecycle: Strong understanding of ICH expectations and practical execution of AQbD, risk-based validation/verification, robustness, and method lifecycle management.
• Analytical platforms & informatics: Strong technical oversight across key analytical modalities and enabling systems (CDS/LIMS/ELN), including standardization and qualification in regulated environments.
• Analytical development breadth: Understanding of analytical development supporting discovery through manufacturing and regulatory submissions.
• Regulatory support: Experience supporting regulatory submissions and approval processes.
• Scientific leadership & stakeholder management: Strong communication/collaboration; able to manage complex priorities and stakeholders.
• Platform modernization: Track record modernizing analytical platforms or scaling new ways of working.