Drug Product Process Scientist - Small Molecules
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 supports supply continuity, launch success, lifecycle excellence, and regulatory compliance, providing senior scientific and technical leadership for products, manufacturing networks, and major workstreams. The position leads technical lifecycle strategies, technology transfers, validation programs, process optimization, and manufacturing network strategies to improve patient outcomes and business performance. It leads integrated execution across internal functions, manufacturing sites, contract manufacturing organizations (CMOs), suppliers, and other external partners, while managing complex dependencies and stakeholder expectations. The role also represents Drug Product Process Sciences in governance and cross-functional decision forums and provides trusted technical advice to internal leaders, partners, auditors, and regulatory agencies. The role is expected to deliver results supporting patient supply, commercial success, regulatory commitments, and launch readiness; improve process robustness, yield, compliance, efficiency, and operational performance; and proactively identify and mitigate technical, supply, quality, regulatory, capacity, and business risks. It applies Takeda Leadership Behaviors by thinking strategically and delivering priorities.
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 use structured problem solving, statistics, and process-robustness methodologies.
- Program and portfolio leadership capability.
- 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.
- 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 Manufacturing, Quality, Regulatory Affairs, Pharmaceutical Sciences, Supply Chain, sites, CMOs, and external partners.
- Define and execute manufacturing, sourcing, technology transfer, validation, and manufacturing network capability strategies.
- Own technical lifecycle strategies and roadmaps; identify risks, opportunities, and investment considerations and contribute recommendations to portfolio and lifecycle discussions.
- Drive continuous improvement initiatives to improve robustness, yield, compliance, efficiency, and operational performance.
- 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; proactively align stakeholders, resolve issues, and manage decisions 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.
- Apply structured problem solving, statistics, and process-robustness methodologies to complex technical challenges.
- Serve as a trusted technical advisor and representative with internal leadership, external partners, auditors, and regulatory agencies.
- Deliver outcomes supporting patient supply, commercial success, regulatory commitments, launch readiness, compliance, process robustness, manufacturing performance, and lifecycle value generation.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
