Global Manufacturing Sciences Process Science Lead – Small Molecules API
Takeda
full-time
Posted on:
Location Type: Office
Location: Boston • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $137,000 - $215,270 per year
Job Level
Senior
About the role
- Lead and support process design, scale-up, technology transfer, and commercial manufacturing support for small molecule drug substance
- Act as SME to troubleshoot complex manufacturing issues, drive effective problem solving and technical decision-making
- Use statistical analysis to interpret manufacturing data, identify root causes, and enable continuous improvement
- Manage drug substance manufacturing activities for assigned programs, coordinating with external partners
- Drive strong technical execution with contract manufacturers
- Author and review key CMC and quality deliverables
- Provide regulatory CMC support for global submissions
- Ensure documentation and execution meet internal procedures and regulatory expectations
- Maintain adherence to quality systems
- Apply lifecycle thinking to development and commercial programs
- Communicate complex technical topics to stakeholders
- Coach and mentor colleagues when appropriate
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)
- Knowledge and manufacturing experience with ADC (Antibody drug conjugates) is an advantage
- Strong understanding of ICH and global regulatory guidelines
- 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)
- Experience using statistical tools for data evaluation and decision-making is highly desired
- Ability to travel up to 20%, domestic & international
Benefits
- Medical, dental, vision insurance
- 401(k) plan and company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Accrual of up to 120 hours of paid vacation per year
- Up to 80 hours of sick time per calendar year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical analysismanufacturing data interpretationproblem solvingtechnical decision-makingdrug substance manufacturingCMC authoringregulatory submissionsquality systemslifecycle thinkingpilot plant manufacturing
Soft skills
communicationcoachingmentoring
Certifications
MScPhD