Drug Product Process Scientist - Small Molecule

USA - 3345 Takeda Manufacturing U.S.A., Inc; Cambridge (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda seeks a Drug Product Process Scientist - Small Molecule in Cambridge, MA to lead technical lifecycle strategies, tech transfers, validation, and continuous improvement across multiple sites and partners. You will own programs, drive risk mitigation, and collaborate with Regulatory CMC, Quality, and Supply Chain to ensure supply and launch readiness.

Ideal candidates have extensive experience in drug product development, manufacturing, and lifecycle management, with strong leadership and

Qualifications

• Advanced degree in chemical engineering, pharmaceutical sciences, chemistry, biology, or related field.
• 10–20 years of relevant pharmaceutical or biotechnology industry experience.
• Experience with drug product manufacturing, technology transfer, validation, lifecycle management.

Responsibilities

• Lead complex technical programs with cross-functional dependencies.
• Own technical lifecycle strategies and roadmaps for products and networks.
• Represent Drug Product Process Sciences in governance forums.
• Drive continuous improvement for robustness, yield, and compliance.

Skills

Leadership

Cross-functional collaboration

Problem solving

Regulatory knowledge

Education

Ph.D./M.S./B.S. in Chemical Engineering or related field

Job description

Drug Product Process Scientist - Small Molecule

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.
• 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 20-25% 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: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 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 job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Worker Type

Employee

Worker Sub-Type

Regular Time Type Full time

Job Exempt

Yes

Legal Notice

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Company Culture:

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives - including your own.

Equal Opportunity Employer

Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions:

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