Analytical LCM Portfolio Lead

Takeda • Lexington, MA

6d • $212,000 - $333,190 • Hybrid

About The Position

This 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. The position ensures analytical LCM method risk registers are standardized, created and maintained across the portfolio and network. It monitors 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, the role provides functional leadership for all Analytical LCM Program representatives, ensuring consistent scientific direction, portfolio prioritization, capability building, and clear accountability for program deliverables. The role also oversees Analytical LCM Portfolio resourcing management by setting and executing the enterprise Analytical resourcing strategy and prioritizing analytical portfolio needs across internal and external labs in collaboration with analytical program leads and laboratory scientists. It serves as a strategic interface with key stakeholders on cross-modality portfolio planning of new CMC processes, analytical development technical and product strategies, roadmaps & initiatives. The role embeds AQbD and risk-based thinking in method development, qualification/validation, and lifecycle management to improve robustness, reduce investigations, and accelerate tech transfer and comparability.

Requirements

• BS/MS in Chemistry, Pharmaceutical Sciences, or related discipline (PhD preferred).
• 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.
• 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.
• Strong understanding of ICH expectations and practical execution of AQbD, risk-based validation/verification, robustness, and method lifecycle management.
• Strong technical oversight across key analytical modalities and enabling systems (CDS/LIMS/ELN), including standardization and qualification in regulated environments.
• Understanding of analytical development supporting discovery through manufacturing and regulatory submissions.
• Experience supporting regulatory submissions and approval processes.
• Strong communication/collaboration; able to manage complex priorities and stakeholders.
• Track record modernizing analytical platforms or scaling new ways of working.

Responsibilities

• 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.
• 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.

Benefits

• Compensation may vary for candidates considered in other locations.
• Location-specific salary ranges and compensation information will be provided in accordance with local requirements.
• Equitable pay for all employees
• Transparency with pay practices
• Base Salary Range: $212,000.00 - $333,190.00
• 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 job.
• Actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior