Drug Product Process Scientist - Small Molecule
About The Position
The Drug Product Process Scientist serves as the accountable technical owner and strategic leader for assigned commercial and late-stage small-molecule drug product portfolios. The role supports supply continuity, launch success, lifecycle excellence, regulatory compliance, patient outcomes, and business performance. It provides senior scientific and technical leadership for products, manufacturing networks, or major workstreams. The position leads technical lifecycle strategies, technology transfers, validation programs, process optimization, and manufacturing network strategies. It coordinates execution across internal functions, sites, contract manufacturing organizations (CMOs), suppliers, and external partners; assesses and mitigates technical and operational risks; and represents Drug Product Process Sciences in governance forums and with external stakeholders. The role also applies Takeda Leadership Behaviors by thinking strategically, inspiring others, delivering priorities, and elevating organizational capabilities. Travel is approximately 20–25% domestically and internationally, based on business needs. The role is listed as a regular, full-time employee position.
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.
- Experience with program and portfolio leadership.
- Ability to think strategically and align technical decisions with long-term patient, business, and portfolio objectives.
- 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 Manufacturing, Quality, Regulatory Affairs, Pharmaceutical Sciences, Supply Chain, and external partners.
- Develop 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.
- Lead continuous improvement initiatives to improve process 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.
- Lead complex investigations, root-cause analyses, CAPAs, change controls, and issue resolution activities.
- Proactively align stakeholders, resolve issues, manage decisions, and minimize escalations.
- Represent Drug Product Process Sciences in governance, leadership, and cross-functional decision forums.
- Serve as a technical representative and trusted advisor to internal leadership, external partners, auditors, and regulatory agencies.
- Manage complex dependencies and stakeholder expectations across functions, sites, CMOs, and external partners.
- Apply structured problem solving, statistics, and process robustness methodologies to technical challenges.
Benefits
- Takeda offers employee benefits; specific benefits are not detailed in the job description.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
