Drug Product Process Scientist - Small Molecules

Takeda Pharmaceutical Co.; Boston (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda Pharmaceutical Co. seeks a Drug Product Process Scientist - Small Molecule at Sr. Manager level in Cambridge, MA.

You will serve as the accountable technical owner and strategic leader for assigned drug product portfolios, ensuring supply continuity, launch readiness, lifecycle excellence, and regulatory compliance across networks. Responsibilities include leading complex technical programs, technology transfers, validation, process optimization, and cross-functional execution with

Qualifications

• Ph.D./MS/BS in chemical engineering, pharmaceutical sciences, chemistry, biology or related field.
• 10–20 years of pharmaceutical/biotech experience with leadership roles.
• Experience leading drug product manufacturing, tech transfer, validation, and lifecycle management.
• Experience across global manufacturing networks including internal sites and CMOs.

Responsibilities

• Lead complex technical programs with cross-functional dependencies to meet quality, cost, and supply goals.
• Drive process robustness, yield, compliance, and operational performance improvements.
• Act as accountable technical owner for products, networks, or major workstreams.
• Lead cross-functional execution across Manufacturing, Quality, Regulatory Affairs, and Supply Chain.
• Define and implement manufacturing, sourcing, transfer, validation, and network strategies.
• Mentor teams and provide data-driven recommendations to senior stakeholders.

Skills

Leadership

Cross-functional leadership

Program management

Regulatory CMC

Tech transfer

Process optimization

GMP compliance

Education

PhD in Chemical Engineering

MS in Pharmaceutical Sciences

BS in Chemistry

Job description

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.
• 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:

$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