Lead Process Scientist, Drug Product (Sr. Manager)

Takeda • Boston, MA

6d

About The Position

Embedded in our Global Manufacturing Science (GMSci) team, you will provide process science and manufacturing technology leadership for drug product manufacturing across Takeda’s global network. You will act as a technical SME for small molecule oral solid dosage and/or parenteral processes, supporting both new product introductions and lifecycle management of marketed products. Working in a matrix environment, you will align cross-functional stakeholders and external partners to enable robust, compliant, and scalable manufacturing. You will also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible filing content. Overall, you will help strengthen how Takeda applies process knowledge consistently across sites to improve execution and decision-making.

Requirements

• Degree (BS, MS, and/or PhD) in Chemistry, Chemical Engineering, or a related discipline (or equivalent combination of education and experience).
• At least 5 years of relevant industry experience, with experience supporting pharmaceutical development and/or manufacturing in DP-related areas (e.g., OSD and/or parenterals).
• Demonstrated success as an SME and project leader in a matrix environment, influencing technical decisions across functions and sites without relying on direct authority.
• Strong working knowledge of DP manufacturing technologies, validation and tech transfer principles, and practical application of industry best practices.
• Experience contributing to or leading regulatory CMC readiness, including converting process understanding into clear technical narratives and defensible control strategies.
• Proven ability to analyze complex problems, drive to root cause, and implement sustainable solutions with high technical rigor.
• Communication and stakeholder-management skills that enable effective collaboration, conflict resolution, and alignment across internal teams and external partners.
• A working style that prioritizes focus, accountability, and measurable outcomes, while actively building capability for the future.

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 Process characterization and establishment of process understanding
• Serve as an escalation point for complex technical investigations and issue resolution, mobilizing and coordinating rapid cross-site support when needed.
• Drive manufacturing strategies for assigned key products, ensuring the approach is consistent across Takeda’s internal network and CMOs and is grounded in process knowledge and science-based risk management.
• Lead continuous improvement for late-phase/matured products by identifying and advancing opportunities that improve robustness, control strategy, and operational performance without compromising compliance.
• Partner effectively in a matrix environment with key stakeholders, including: Pharmaceutical Sciences counterparts (R&D) Manufacturing site and operating unit leaders Local Technical Services organizations Global Quality and Regulatory CMC teams
• Ensure process knowledge is captured, shared, and reused across sites and functions to strengthen Takeda’s overall DP manufacturing capability and speed decision-making.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees