Analytical LCM Portfolio Lead

USA - 3345 Takeda Manufacturing U.S.A., Inc; Lexington (MA); On-site; USD 212,000 - 333,000; Full time

Job summary

Takeda in Lexington, MA seeks a senior leader to own and drive Analytical LCM Portfolio Standardization & Governance across modalities, ensuring robust scientific direction and accountable program delivery.

You will establish risk-based, AQbD-driven strategies, oversee resourcing, and collaborate with QA, QC, Regulatory CMC, and IT to support submission-ready documentation and lifecycle management across the network.

Qualifications

• 12+ years in pharma/biotech with depth in Analytical Development and/or QC.
• Experience leading strategy, governance, and delivery across multiple programs including NDA/BLA.
• AQbD, risk-based validation/verification, and lifecycle management.
• Experience supporting regulatory submissions.
• Strong communication and stakeholder management.
• Track record modernizing analytical platforms.

Responsibilities

• Lead standardization and governance of Analytical LCM portfolio across modalities.
• Provide leadership for Analytical LCM Program representatives with clear accountability.
• Coordinate cross-functional resourcing and strategic portfolio planning.
• Collaborate with QA, QC, Manufacturing, Regulatory CMC, and IT to ensure readiness.

Skills

Analytical development

QC oversight

Regulatory submissions

Cross-functional leadership

People management

Education

BS/MS in Chemistry/Pharmaceutical Sciences

PhD preferred

Tools

CDS/LIMS/ELN

Job description

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. 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.

Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location: Lexington, MA U.S. Base Salary Range: $212,000.00 - $333,190.00 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 job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MAAUT - Linz - St. Peter Strasse 25, AUT - Wien - DC Tower, CHE - Glattpark (Opfikon) - Zurich HQ, IRL - Dublin - Baggot Street, JPN - Yamaguchi - Hikari

Worker Type

Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

About Takeda

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to stride towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.