Drug Product Process Scientist - Small Molecule

Takeda • Boston, MA

1d • $154,400 - $242,550

About The Position

The Drug Product Process Scientist serves as the accountable technical owner and strategic leader for assigned commercial and late-stage drug product portfolios. The role is responsible for supply continuity, launch success, lifecycle excellence, and regulatory compliance, and provides senior scientific and technical leadership for assigned products, manufacturing networks, or major workstreams.

The position leads development and execution of technical lifecycle strategies, technology transfers, validation programs, process optimization initiatives, and manufacturing network strategies to improve patient outcomes and business performance. It oversees complex, cross-functional technical programs and integrates execution across Manufacturing, Quality, Regulatory Affairs, Pharmaceutical Sciences, Supply Chain, and external partners. The role also leads risk assessments, investigations, root-cause analyses, CAPAs, change controls, and issue resolution; represents Drug Product Process Sciences in governance forums; and provides data-driven recommendations to senior stakeholders.

The position is based in the Boston, Massachusetts area and requires approximately 20–25% domestic and international travel, based on business needs. The stated U.S. base salary range is $154,400–$242,550. The actual offer may vary based on qualifications, experience, skills, education, credentials, and location.

Requirements

• Ph.D., M.S., or B.S. in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or a related technical discipline.
• Typically 10–20 years of relevant pharmaceutical or biotechnology industry experience.
• Demonstrated success leading complex drug product manufacturing, process development, technology transfer, validation, lifecycle management, and commercial supply activities.
• Experience working across global manufacturing networks, including internal sites and CMOs.
• Ability to independently manage multiple priorities and projects.
• Expert-level knowledge of drug product process development and commercial manufacturing.
• Knowledge of process characterization, validation, and continued process verification.
• Knowledge of technology transfer and scale-up.
• Knowledge of quality risk management and GMP compliance.
• Knowledge of Regulatory CMC submissions and lifecycle management.
• Ability to apply structured problem solving, statistics, and process robustness methodologies to complex technical challenges.
• Experience leading programs and portfolios.
• Ability to lead integrated work across internal manufacturing locations, external partners, CMOs, suppliers, global functional teams, Quality, Regulatory CMC, Pharmaceutical Sciences, Technical Operations, and Supply Chain partners.
• Ability to think strategically, align technical decisions with long-term patient, business, and portfolio objectives, and anticipate future manufacturing needs.
• Ability to focus teams on critical priorities and deliver outcomes while balancing competing demands, quality, compliance, and business performance.

Responsibilities

• Serve as the accountable technical owner for assigned products, manufacturing networks, or major workstreams.
• Lead complex technical programs and integrated execution across functions, sites, CMOs, and external partners while meeting quality, cost, timeline, and supply objectives.
• Own technical lifecycle strategies and roadmaps for assigned products and manufacturing networks; identify risks, opportunities, and investment considerations.
• Define and execute manufacturing, sourcing, technical transfer, validation, and network capability strategies.
• Lead technology transfers, validation programs, process optimization, scale-up, and lifecycle management activities.
• Drive continuous improvement to improve process robustness, yield, compliance, efficiency, and operational performance.
• Lead technical risk assessments and mitigation plans across products, sites, and manufacturing networks; anticipate supply, quality, regulatory, capacity, and business risks.
• Provide data-driven recommendations and drive timely decisions among senior stakeholders; proactively align stakeholders and resolve issues to minimize escalations.
• Lead complex investigations, root-cause analyses, CAPAs, change controls, and issue-resolution activities.
• Represent Drug Product Process Sciences in governance, leadership, and cross-functional decision forums, and serve as a trusted technical representative with internal leadership, external partners, auditors, and regulatory agencies.
• Contribute recommendations to broader portfolio and product lifecycle discussions.
• Apply Takeda Leadership Behaviors, including strategic thinking, inspiring others, delivering priorities, and elevating organizational capabilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior