Analytical LCM Portfolio Lead

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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.

• 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 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.

• 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.
  

• 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.

The salary range displayed reflects the primary location associated with this posting. Compensation may vary for candidates considered in other locations. Where applicable location-specific salary ranges and compensation information will be provided in accordance with local requirements.

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The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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