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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.
Skills Required
- Associate degree with 7 or more years, bachelor's degree with 5 or more years, or master's degree with 3 or more years of relevant industry experience in biologics analytical development
- Hands-on laboratory experience
- Practical expertise in biologics analytical techniques, including HPLC or UPLC, CE-SDS, electrophoresis, isoelectric focusing, or ELISA assays
- Ability to independently plan and execute experiments, analyze data, interpret results, and communicate conclusions
- Ability to prepare and review protocols, reports, data summaries, method documents, SOPs, and technology transfer materials
- Demonstrated technical troubleshooting and problem-solving skills
- Ability to collaborate across departments and manage project timelines, deliverables, and data quality expectations
- Understanding of data integrity, ELN or LIMS documentation, laboratory safety, and good documentation practices
- Ability to manage multiple priorities while maintaining scientific quality, timelines, and documentation standards
- Clear written, verbal, and technical presentation communication skills
- Working knowledge of Analytical Quality by Design principles and ICH guidelines
- Experience with laboratory automation, including liquid handlers, dispensers, SCARA robots, or mobile robots
- Experience with laboratory information management systems and digital or AI tools
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Retirement benefits include a dollar-for-dollar 401(k) match with immediate vesting, plus an additional annual contribution that increases with age and service. These features are positioned as a notable strength in the U.S. offering.
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Parental & Family Support — Family supports span extended paid bonding leave alongside fertility, adoption, surrogacy, childcare, and caregiver resources. The scope of these programs is broad and prominent within the package.
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Healthcare Strength — Health coverage spans PPO and HSA-enabled options with prescription, dental, and vision, complemented by mental-health support and a 24/7 EAP. The breadth of coverage and wellness resources is a recurring highlight.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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