Analytical LCM Portfolio Lead

3345 Takeda Manufacturing U.•Lexington, MA

About The Position

The Analytical LCM Portfolio Lead owns and drives standardization and governance for analytical lifecycle management (LCM) portfolio strategies across modalities, with a focus on commercial analytical control strategies, methods, and specifications. The role establishes and maintains processes and RACI, supports consistent and scientifically sound decision-making, and aligns portfolio strategy with pipeline needs. The position provides portfolio-wide analytical oversight, including standardized method risk registers, analytical LCM roadmaps, and strategies to address at-risk methods. It provides functional leadership for Analytical LCM program representatives and oversees resourcing priorities across internal and external laboratories. The role partners with stakeholders across the organization to plan cross-modality CMC processes, analytical development strategies, roadmaps, and initiatives. The Lead embeds AQbD and risk-based approaches in method development, qualification, validation, and lifecycle management. The role also supports governance and quality oversight, inspection readiness, data integrity and documentation practices, method transferability, submission readiness, change control, knowledge management, metrics, and continuous improvement. The position is based primarily in Lexington, Massachusetts; qualified internal candidates in Zurich, Linz, Dublin, Vienna, or Hikari may also be considered, subject to business needs and other stated conditions.

Requirements

BS or MS in Chemistry, Pharmaceutical Sciences, or a related discipline.
12+ years of experience in pharma or biotech, with depth in Analytical Development and/or QC.
Significant people and matrix leadership experience, with accountability for strategy, governance, and delivery across multiple programs, including NDA or BLA filings.
Demonstrated experience developing analytical and holistic control strategies and supporting regulatory submissions such as IND, IMPD, BLA, NDA, or MAA, including specifications and justifications, stability, and comparability strategies.
Strong understanding of ICH expectations and practical execution of AQbD, risk-based validation or verification, robustness, and method lifecycle management.
Technical oversight across key analytical modalities and enabling systems such as CDS, LIMS, and 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 and collaboration skills, with the ability to manage complex priorities and stakeholders.

Nice To Haves

PhD in Chemistry, Pharmaceutical Sciences, or a related discipline.
Track record of 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 a standardized approach for portfolio analytical LCM strategies—including method capabilities, specifications, and comparability—across modalities and the network.
Establish and drive Analytical LCM Portfolio Standardization and Governance for analytical commercial control strategies, methods, and specifications, including RACI and processes, in collaboration with GSQ and Pharm Sci.
Standardize, create, and maintain analytical LCM method risk registers across the portfolio and network; monitor them with analytical program leads and develop roadmaps and strategies for at-risk methods.
Provide functional leadership for Analytical LCM program representatives, supporting consistent scientific direction, portfolio prioritization, capability building, and accountability for deliverables.
Oversee analytical LCM portfolio resourcing management; set and execute the enterprise analytical resourcing strategy and prioritize portfolio needs across internal and external laboratories.
Coordinate with Pharm Sci and BD to integrate incoming portfolio program analytical strategies into commercial lifecycle management.
Partner with key stakeholders on cross-modality portfolio planning for new CMC processes, analytical development technical and product strategies, roadmaps, and initiatives.
Embed AQbD and risk-based thinking in method development, qualification, validation, and lifecycle management to improve robustness, reduce investigations, and accelerate technology transfer and comparability.
Ensure analytical governance and quality oversight across the network, including standards, training, inspection readiness, data integrity, and documentation practices.
Establish analytical LCM roadmap standards, templates, and governance for method development and validation or verification, including robustness and risk assessments.
Prioritize analytical LCM work by assessing organizational capacity and internal versus external work.
Build organizational capability in method risk registers and proactively implement measures to keep products and methods in control throughout their use.
Partner with QA, QC, Manufacturing/MSAT, Regulatory CMC, Supply Chain, Pharm Sci, and IT on submission-ready analytical sections, inspection readiness, and governance for change control and lifecycle management.
Drive Analytical LCM Portfolio Excellence through ways of working, knowledge management, metrics, and continuous improvement to improve throughput, compliance, and quality outcomes.