Global Manufacturing Sciences Process Science Lead – Small Molecules API (Sr. Manager)

Takeda•Boston, MA

2d•$137,000 - $215,270

About The Position

This senior individual contributor role in Global Manufacturing Science (GMSci) is the subject matter expert and primary technical contact for Takeda’s small molecule API manufacturing for synthetic drug substance across the product lifecycle. You will define and drive phase-appropriate, fit-for-purpose manufacturing strategies, applying deep drug substance expertise and direct manufacturing experience to support process design, scale-up, technology transfer, and commercial supply. Working cross-functionally, you will provide clear, evidence-based technical recommendations, communicate risks and options, and influence decisions that strengthen manufacturing robustness and supply continuity. As needed, you will represent Small Molecule Drug Substance in forums with partners including Regulatory, Quality, Analytical Services, Supply Chain, R&D, and functional leadership.

Requirements

Advanced degree (MSc or PhD) in Chemistry, Chemical Engineering, Pharmacy, or a closely related field.
At least 5 years of relevant experience in the pharmaceutical industry.
Direct experience in pilot plant manufacturing of synthetic drug substance (API); ADC (Antibody drug conjugates) knowledge and manufacturing experience is an advantage.
Strong understanding of ICH and global regulatory guidelines and how they apply to drug substance manufacturing and control.
Experience with phase-appropriate development and clinical supply processes.
Demonstrated experience authoring CMC sections for regulatory submissions (e.g., IND/IMPD/NDA/MAA).
Proven SME-level experience working within quality systems (deviations/investigations, CAPAs, change controls, etc.).
Experience using statistical tools for data evaluation and decision-making is highly desired.
Ability to travel up to 20%, domestic & international

Nice To Haves

Beneficial would be knowledge of EU and US CMC requirements and familiarity with inspection expectations (e.g., MHRA/FDA) and compliance practices.

Responsibilities

Lead and/or support process design, scale-up, technology transfer, and ongoing commercial manufacturing support for small molecule drug substance including Antibody-Drug Conjugates (ADCs).
Act as SME to troubleshoot complex manufacturing issues, including deviations and investigations; drive effective, timely problem solving and technical decision-making.
Use appropriate tools (including statistical analysis) to interpret manufacturing data, identify root causes, and enable continuous improvement.
Manage drug substance manufacturing activities for assigned programs, including coordination of external partners (CROs/CMOs).
Drive strong technical execution with contract manufacturers, ensuring successful tech transfers and effective collaboration during troubleshooting and optimization.
Author and/or review key CMC and quality deliverables, such as: protocols, validation reports, methods, technology transfer reports investigation reports and technical reports supporting submissions
Provide regulatory CMC support by authoring/reviewing drug substance (and relevant drug product) CMC sections for global submissions (e.g., IND/NDA/MAA and annual reports) and supporting responses to health authority questions and changes.
Ensure documentation and execution meet internal procedures and regulatory expectations; contribute to a culture of inspection readiness, including participation in audit/inspection preparation and coordination.
Maintain strong adherence to quality systems (e.g., SOP training, deviations/investigations, CAPAs, change controls) and support continuous improvement of departmental processes.
Apply lifecycle thinking (including QbD principles) to development and commercial programs.
Contribute to sustainability improvements in drug substance manufacturing in alignment with Takeda’s corporate Planet goals.
Communicate complex technical topics clearly and concisely to both technical and non-technical stakeholders; prepare targeted updates and presentations for management as needed.
Coach and/or mentor colleagues when appropriate, supporting capability building across problem-solving and technical excellence.

Benefits

U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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