Drug Product Process Scientist - Small Molecules
Takeda
Summary
You will serve as the accountable technical owner and strategic leader for assigned commercial and late-stage drug product portfolios, ensuring supply continuity, launch success, lifecycle excellence, and regulatory compliance. You will provide senior scientific and technical leadership for assigned products, manufacturing networks, or major workstreams. You will lead development and execution of technical lifecycle strategies, technology transfers, validation programs, process optimization initiatives, and manufacturing network strategies that improve patient outcomes and business performance.
Job description
About the role
You will serve as the accountable technical owner and strategic leader for assigned commercial and late-stage drug product portfolios, ensuring supply continuity, launch success, lifecycle excellence, and regulatory compliance. You will provide senior scientific and technical leadership for assigned products, manufacturing networks, or major workstreams. You will lead development and execution of technical lifecycle strategies, technology transfers, validation programs, process optimization initiatives, and manufacturing network strategies that improve patient outcomes and business performance.
How will you contribute
- Consistently delivers high-impact outcomes across products, programs, and strategic initiatives that support patient supply, commercial success, regulatory commitments, and launch readiness.
- Lead complex technical programs with significant cross-functional dependencies while ensuring achievement of quality, cost, timeline, and supply objectives.
- Drive continuous improvement initiatives that improve robustness, yield, compliance, efficiency, and operational performance.
- Act as accountable technical owner for assigned products, manufacturing networks, or major workstreams.
- Lead integrated execution across Manufacturing, Quality, Regulatory Affairs, Pharmaceutical Sciences, Supply Chain, and external partners.
- Define and executes manufacturing, sourcing, technical transfer, validation, and network capability strategies.
- Minimize escalations through proactive stakeholder alignment, issue resolution, and decision management.
- Own technical lifecycle strategies and roadmaps for assigned products and manufacturing networks.
- Identify risks, opportunities, and investment considerations.
- Contribute recommendations that inform broader portfolio and product lifecycle discussions.
- Lead technical risk assessments and mitigation plans across products, sites, and manufacturing networks.
- Anticipate emerging supply, quality, regulatory, capacity, and business risks before they impact operations.
- Provide data-driven recommendations and drives timely decisions among senior stakeholders.
- Lead complex investigations, root-cause analyses, CAPAs, change controls, and issue resolution activities.
- Represent Drug Product Process Sciences credibly in relevant governance forums.
- Align stakeholders to advance decisions within assigned scope.
What you bring to Takeda
- Ph.D., M.S., or B.S. in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or 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.
- Demonstrated ability to independently manage multiple priorities and projects.
- Drug product process development and commercial manufacturing.
- Process characterization, validation, and continued process verification.
- Technology transfer and scale-up.
- Quality risk management and GMP compliance.
- Regulatory CMC submissions and lifecycle management.
- Structured problem solving, statistics, and process robustness methodologies.
- Program and portfolio leadership.
Additional Information
Travel required approximately 20–25% domestic and international, based on business needs.
Requirements
- Ph.D., M.S., or B.S. in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or 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.
- Demonstrated ability to independently manage multiple priorities and projects.
- Drug product process development and commercial manufacturing.
- Process characterization, validation, and continued process verification.
- Technology transfer and scale-up.
- Quality risk management and GMP compliance.
- Regulatory CMC submissions and lifecycle management.
- Structured problem solving, statistics, and process robustness methodologies.
- Program and portfolio leadership.
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.