Drug Product Process Scientist Small Molecule

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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. You will also apply Takeda Leadership Behaviors by thinking strategically inspiring others delivering priorities and elevating capabilities across the organization.

• 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.
• 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.
• Expert-level knowledge of drug product process development commercial manufacturing process characterization validation continued process verification technology transfer scale-up quality risk management GMP compliance Regulatory CMC submissions and lifecycle management.
• 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.
• Apply structured problem solving statistics and process robustness methodologies to complex technical challenges.
• Work across internal manufacturing locations external partners CMOs suppliers global functional teams Quality Regulatory CMC Pharmaceutical Sciences Technical Operations and Supply Chain partners.
• Serve as a trusted advisor and technical representative with internal leadership external partners auditors and regulatory agencies.
• Represent Drug Product Process Sciences in governance leadership and cross-functional decision forums.
• Accountable technical owner for multiple products platforms or major technical workstreams with significant business supply quality compliance or launch impact.
• Directly influences product supply launch readiness compliance process robustness manufacturing performance and lifecycle value generation across the portfolio.
• Lead integrated execution across multiple functions sites CMOs and external partners while managing complex dependencies and stakeholder expectations.

• 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.
• Think Strategically: Demonstrates enterprise thinking and aligns technical decisions with long-term patient business and portfolio objectives while anticipating trends technologies and future manufacturing needs.
• Deliver Priorities: Focuses teams on critical priorities and consistently delivers superior outcomes while balancing competing demands quality compliance and business performance.

ADDITIONAL INFORMATION

Travel required approximately 2025% domestic and international based on business needs.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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