About the Role:
The Senior Scientist - Analytical Development and Transfer is responsible for providing scientific leadership for analytical technology transfers across the CMC portfolio. This role drives analytical transfer strategy, governance, and execution to ensure successful delivery of site readiness activities, transfer milestones, and compliant analytical methods across internal laboratories, manufacturing sites, and external partners.
The position contributes to the development of robust, sustainable, and inspection-ready analytical control strategies by establishing and overseeing transfer, validation, and verification activities. The individual serves as a technical authority for analytical transfers, supports regulatory and compliance objectives, and partners across functions to ensure high standards of quality, reliability, and operational excellence.
How You Will Contribute:
- Develop and execute analytical technology transfer strategies across multiple programs, ensuring successful delivery of transfer milestones, site readiness activities, and lifecycle management objectives.
- Lead or influence complex analytical transfer programs, providing scientific and strategic guidance across internal laboratories, manufacturing sites, and external analytical partners.
- Establish, govern, and continuously improve transfer documentation, including protocols, validation and verification plans, acceptance criteria, risk assessments, templates, and best practices.
- Manage key analytical vendor and contract laboratory relationships, including performance monitoring, governance reviews, escalation management, and accountable delivery of transfer commitments.
- Serve as a technical authority and escalation point for complex analytical issues, method performance challenges, investigations, deviations, and risk assessments, driving scientifically sound solutions and corrective actions.
- Partner with Analytical Development, Quality Assurance, Quality Control, Manufacturing, MSAT, Regulatory CMC, Supply Chain, and other stakeholders to align priorities, resolve issues, and deliver business objectives.
- Contribute significantly to departmental scientific strategy and operational excellence initiatives by establishing scalable ways of working, governance models, and knowledge-sharing frameworks.
- Identify improvement opportunities and lead local and global initiatives focused on analytical transfer excellence, inspection readiness, network performance, and right-first-time execution.
- Mentor and develop scientific staff through coaching, technical review, training programs, and adoption of analytical transfer standards and best practices.
- May have direct reports.
Skills and Qualifications:
- Fully adept in Good Manufacturing Practices (GMP) and GxP environments. Demonstratedsuccess in GMP/QC-facing settings with a strong inspection readiness and data integrity (ALCOA+) mindset.
- Advanced understanding of analytical method transfer, co-validation, and verification activities. Experience leading end-to-end method transfers and/or co-validations across sites and CMOs (strategy, protocols, acceptance criteria, training, execution oversight, and final reports).
- Expert knowledge of risk-based validation and verification principles, including ICH guidance. Strong understanding of ICH expectations and the ability to execute risk-based validations
- Advanced proficiency in analytical techniques, including HPLC and related methodologies.
- Advanced writing and documentation skills for protocols, reports, and regulatory documentation.
- Advanced ability to apply innovation and continuous improvement principles.
- Strong knowledge of analytical development across the product lifecycle.
- Experience supporting regulatory submissions and inspection readiness activities.
- Excellent stakeholder management and communication skills.
What Takeda Can Expect From You:
As an expert professional within the organization, you develop innovative solutions to complex analytical technology transfer and governance challenges aligned with organizational objectives. Your work involves addressing intricate scientific, technical, operational, and compliance issues, requiring deep analytical expertise, sound judgment, and strategic thinking.
You regularly engage with key internal and external stakeholders, contribute to the development of new standards and best practices, and influence scientific and business decisions across the analytical network. Operating with considerable autonomy, you serve as a consultant to management and a recognized technical authority for analytical transfer activities. You may lead functional teams, drive cross-organizational initiatives, and play a significant role in mentoring and developing scientific talent while advancing Takeda’s analytical capabilities and operational excellence.
