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:

• BS, MS, or equivalent advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, Biotechnology, or related scientific discipline preferred.
• Bachelor’s degree with significant relevant experience may be considered.
• Typically 5-15 years of pharmaceutical industry experience.
• Demonstrated experience in drug product process development, technology transfer, commercial manufacturing support, validation, lifecycle management, and regulatory submissions.
• Experience leading cross-functional teams and influencing stakeholders in a global matrix environment.
• Experience supporting product launches and regulatory interactions preferred.
• Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, scientific problem solving and risk management.
• Excellent communication, collaboration, and stakeholder management skills.
• Demonstrated ability to independently manage multiple priorities and projects.
• Knowledge of process validation, CPV, QbD, risk management, and statistical problem-solving methodologies.
• Lean, Six Sigma, or Operational Excellence experience is preferred.
• Regulatory and GMP expertise.
• Decision making under ambiguity.
• Coaching, talent development, negotiation, and stakeholder management.
• Continuous improvement and innovation.
• 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: $137,000.00 - $215,270.00

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.

For information about our benefits, please click here .

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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.