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Job DescriptionYou will report to the Associate Director, Process Analytics Lead within Analytical Development. You will contribute to in-process method development activities for biologics molecules using chromatographic (U/HPLC), electrophoretic and isoelectric focusing (CE-SDS/Maurice®/Lab Chip GXII®) and/or ELISA type techniques. You will independently plan, execute, analyze, and report method development experiments to support product understanding, process development, comparability, stability, manufacturing readiness, technology transfer, and regulatory submissions. You will work with departmental and cross-functional partners to generate high-quality data, troubleshoot technical issues, and communicate results that support decision-making for synthetic molecule programs. This role does not include direct people management.
How you will contribute:
- Independently design, develop, qualify and report fit-for-purpose, scientifically sound and high-throughput analytical methods for in-process testing of biologics molecules under general direction.
- Work closely with in-process analytical testing team within Biologics Process Development (BPD) organization for seamless method transfer and life cycle management.
- Apply Analytical Quality by Design (AQbD) principles and phase-appropriate approaches for method development.
- Partner with Analytical Development, Quality, Compliance, and Stability teams to support method bridging, and transfer activities.
- Work with automation, digital and PAT subject matter experts to validate and integrate technologies and platforms into process analytical methods.
- Evaluate new tools, platforms, and vendor solutions for in-process analytics as needed.
Skills and qualifications:
- Typically associate degree with 7+ years, bachelor’s degree with 5+ years, or master’s degree with 3+ years of relevant industry experience in analytical development for biologics molecules.
- Previous hands-on experience working in a laboratory setting is required.
- Strong expertise and practical knowledge of one or more relevant analytical techniques for testing biologics samples such as liquid chromatography (HPLC/UPLC), electrophoresis and isoelectric focusing (CE-SDS/Maurice®/Lab Chip GXII®) and/or ELISA type assays.
- Ability to independently plan and execute experiments, analyze data, interpret results, and communicate conclusions to technical and cross-functional stakeholders.
- Ability to prepare and review technical documentation, including protocols, reports, data summaries, method documents, SOPs, and technology transfer materials.
- Demonstrated problem-solving skills, including the ability to troubleshoot technical issues, propose practical solutions, and escalate risks appropriately.
- Ability to work across departmental and cross-functional teams with an understanding of project timelines, deliverables, and data quality expectations.
- Understanding of data integrity principles, ELN/LIMS documentation, laboratory safety, and good documentation practices.
- Ability to manage multiple priorities with general direction while maintaining attention to scientific quality, timelines, and documentation standards.
- Ability to communicate technical information clearly in writing and in conversation, and to present technical information clearly to scientific and project stakeholders.
- Working understanding of AQbD principles & ICH guidelines.
- Experience with laboratory automation capabilities, such as liquid handlers, dispensers, SCARA robots, and mobile robots, is highly desirable.
- Experience with laboratory information management systems and other digital or AI tools is desirable.
Takeda Compensation and Benefits Summary:
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually, Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
It is possible the job scope may change at the company’s discretion.
It is possible the department and workplace may change at the company’s discretion.
