Drug Product Process Scientist - Small Molecules

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Job Description

Title: Drug Product Process Scientist - Small Molecule (Sr. Manager)

Location: Cambridge, MA

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

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.
• 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.

What you bring to Takeda:

• Ph.D., M.S., or B.S. in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or related technical discipline.

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