Lead Process Scientist, Drug Product (Sr. Manager)

Role Summary

Lead process science and manufacturing technology leadership for drug product manufacturing within Takeda’s global network. Serve as a technical SME for small molecule oral solid dosage and/or parenteral processes, supporting both new product introductions and lifecycle management. Represent the drug product process science perspective in regulatory CMC interactions and drive consistent application of process knowledge across sites.

Responsibilities

• Lead and/or oversee DP technical deliverables across the product lifecycle, including technology transfer to internal sites and external contract manufacturing organizations (CMOs), process validation planning and execution support, and process characterization to establish process understanding.
• Serve as an escalation point for complex technical investigations and coordinate rapid cross-site support when needed.
• Drive manufacturing strategies for assigned key products, ensuring consistency across Takeda’s internal network and CMOs with risk-based, science-driven approaches.
• Lead continuous improvement for late-phase/matured products by identifying opportunities to improve robustness, control strategy, and operational performance without compromising compliance.
• Partner with key stakeholders in a matrix environment, including Pharmaceutical Sciences (R&D), manufacturing site and operating unit leaders, Local Technical Services, and Global Quality and Regulatory CMC teams.
• Ensure process knowledge is captured, shared, and reused across sites and functions to strengthen Takeda’s DP manufacturing capability and speed decision-making.

Qualifications

• Required: Degree (BS, MS, and/or PhD) in Chemistry, Chemical Engineering, or a related discipline (or equivalent combination of education and experience).
• Required: At least 5 years of relevant industry experience in DP-related pharmaceutical development and/or manufacturing (e.g., OSD and/or parenterals).
• Required: Demonstrated success as an SME and project leader in a matrix environment, influencing technical decisions across functions and sites without direct authority.
• Required: Strong working knowledge of DP manufacturing technologies, validation and tech transfer principles, and application of industry best practices.
• Required: Experience contributing to or leading regulatory CMC readiness, including translating process understanding into clear technical narratives and defensible control strategies.
• Required: Ability to analyze complex problems, drive root cause analysis, and implement sustainable solutions with technical rigor.
• Required: Effective communication and stakeholder-management skills enabling collaboration, conflict resolution, and alignment across internal teams and external partners.
• Required: Focused, accountable working style with a drive for measurable outcomes and building capability for the future.

Education

• Degree (BS, MS, and/or PhD) in Chemistry, Chemical Engineering, or a related discipline (or equivalent).