Senior Manager, Manufacturing Science (MSAT) – Drug Substance (Small Molecules)

Takeda

1d • $137,000 - $215,270

About The Position

In this role, you will serve as Takeda’s senior subject matter expert for synthetic drug substance manufacturing across the full product lifecycle. In this high‑visibility, high‑impact role, you will define and execute the technical strategy that underpins robust, reliable, and sustainable global API supply. You will apply deep expertise in small molecule and/or ADC drug substance manufacturing to shape process design, scale‑up, technology transfer, and commercial production. As the primary technical point of contact for key programs, you will influence global decision‑making, guide complex investigations, and partner closely with cross‑functional leaders in Quality, Regulatory, Analytical Sciences, Supply Chain, and R&D. This position is ideal for a seasoned process scientist who thrives on solving complex technical challenges, driving manufacturing excellence, and ensuring supply continuity for patients worldwide.

Requirements

• Advanced degree (MSc or PhD) in Chemistry, Chemical Engineering, Pharmacy, or related discipline.
• 5+ years of pharmaceutical industry experience in small molecule drug substance development, scale‑up, and pilot‑plant or commercial manufacturing.
• Strong understanding of regulatory expectations, CMC requirements, and global quality systems.
• Demonstrated experience writing CMC sections for regulatory filings.
• Technical proficiency in statistical analysis and data‑driven decision-making.
• Willingness to travel domestically and internationally.

Nice To Haves

• Experience with ADC process development/manufacturing is a strong plus.

Responsibilities

• Lead phase‑appropriate process design, scale‑up, technology transfer, and commercial manufacturing support for small molecule and ADC drug substance, setting technical strategies that enable efficient clinical and commercial supply.
• Serve as the senior technical authority for assigned programs, providing expert guidance, resolving complex manufacturing issues, and driving timely, evidence-based decision-making.
• Apply statistical and data‑driven tools to interpret manufacturing performance, identify root causes, and enable ongoing optimization, improved process robustness, and continuous improvement initiatives.
• Manage external manufacturing activities at CROs and CMOs, ensuring strong technical alignment, successful technology transfers, and effective collaboration on troubleshooting and optimization.
• Author or review key CMC and quality documentation, including validation reports, technology transfer packages, technical reports, and regulatory submission content for IND/IMPD/NDA/MAA filings.
• Support global regulatory interactions by preparing responses to health authority questions and ensuring documentation meets internal standards and external regulatory expectations.
• Maintain strong adherence to quality systems—including deviations, investigations, CAPAs, and change controls—while fostering inspection readiness and participating in audits and compliance activities.
• Apply lifecycle and QbD principles to guide development and commercial programs, contributing to improved process understanding and long‑term manufacturing reliability.
• Identify and support opportunities to enhance sustainability in drug substance manufacturing in line with Takeda’s Planet goals.
• Translate complex scientific concepts into clear, actionable insights for both technical and non‑technical audiences, preparing concise updates and presentations for leadership as needed.
• Mentor and coach colleagues, helping to elevate technical problem-solving skills and support capability building across the organization.

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: Senior