Drug Product Process Scientist - Small Molecules

Takeda•Boston, MA

2d•$137,000 - $215,270

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, providing senior scientific and technical leadership for products, manufacturing networks, and major workstreams. It leads technical lifecycle strategies, technology transfers, validation programs, process optimization, and manufacturing network strategies to improve patient outcomes and business performance. The position leads complex, cross-functional technical programs and integrated execution across manufacturing, quality, regulatory affairs, pharmaceutical sciences, supply chain, and external partners. It owns product and network lifecycle roadmaps, assesses risks and investment considerations, and supports portfolio and lifecycle decisions. The role also leads technical risk assessments, investigations, root-cause analyses, CAPAs, change controls, and issue resolution, and represents Drug Product Process Sciences in governance and other decision forums. Travel is approximately 20–25% domestically and internationally, based on business needs.

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 in program and portfolio leadership.
Ability to lead teams strategically, align technical decisions with long-term patient, business, and portfolio objectives, and deliver priorities while balancing competing demands, quality, compliance, and business performance.
Willingness to travel approximately 20–25% domestically and internationally, based on business needs.

Responsibilities

Serve as accountable technical owner for assigned products, manufacturing networks, or major workstreams.
Lead complex technical programs and integrated execution across functions, sites, contract manufacturing organizations, and external partners.
Develop and execute technical lifecycle, manufacturing, sourcing, technology transfer, validation, and network capability strategies.
Drive continuous improvement to increase process robustness, yield, compliance, efficiency, and operational performance.
Own technical lifecycle strategies and roadmaps for assigned products and manufacturing networks; identify risks, opportunities, and investment considerations.
Lead technical risk assessments and mitigation plans across products, sites, and manufacturing networks, anticipating supply, quality, regulatory, capacity, and business risks.
Provide data-driven recommendations and support timely decisions among senior stakeholders; align stakeholders and minimize escalations through proactive issue resolution and decision management.
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 technical representative with internal leadership, external partners, auditors, and regulatory agencies.
Support patient supply, commercial success, regulatory commitments, launch readiness, compliance, process robustness, manufacturing performance, and lifecycle value generation.