Principal or Associate Scientist, Process Testing & Management Analytical Development Japan Full-time

Job Title

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Please note this job requires business level Japanese in speaking, writing, and reading. （）（＝）（Patient）（Trust）（Reputation）（Business）

ACCOUNTABILITIES:

• J-GMPUS-cGMPEU-GMP（CTM）
• cGMP
• GMP
• ICH
• CTOCDMOR&D
• FDAEMAPMDAICHAnalytical Quality by Design（AQbD）

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• CMC5
• CMC3
• （）GMP
• ；CMC
• cGMP

Better Health, Brighter Future

OBJECTIVES/PURPOSE

• Execute and lead process control and release testing for biologics GMP manufacturing and sterile drug products for clinical trial materials, ensuring rigorous compliance with cGMP standards, quality, and regulatory requirements.
• Execute strategic planning and operational excellence with cross-functional GMP manufacturing and operating team, actively contributing to process & analytical development, technology transfer, and adaptable manufacturing to drive organizational success and elevate in-house analytical capability
• Lead the development of analytical methods, qualification and validation for drug substance and drug product to deliver the high quality and innovative medicines to patients through the strategic planning and execution including specification setting and complex problem solving for pharmaceutical development
• Contribute to pipeline development and strategic discussion to plan/coordinate with cross-functional members and evaluate impact of decisions across Pharm Sci functions and other development functions.

ACCOUNTABILITIES

• Responsible for timely and quality delivery of Biologics clinical trial materials (CTMs) in strict compliance with J-GMP, US-cGMP, and EU-GMP standards.
• Create the holistic process and quality control strategy that aligns with Takeda's quality expectations, minimizes compliance risks, and ensures cGMP compliance
• Lead internal staff and coordinate with outsourced personnel/vendors to execute the analytical control strategy effectively.
• Lead and implement strategies to ensure readiness for internal and external GMP regulatory inspections.
• Collaborate with Global Quality colleagues to identify and implement improvements that enhance global operations.
• Develop and validate ICH compliant and reliable analytical methods for drug substnace and drug products of synthetic molecules in phase appropriate manner.
• Build and maintain good partnership with internal / external partners such as CTOs, CDMOs and Takeda's R&D and commercial organizations.
• Understand and implement regulatory knowledge such as FDA, EMA, PMDA and ICH guidelines for analytical development, stability studies and analytical Quality by Design (QbD).
• Deliver sound scientific experiments that lead to high quality and reliable data to make critical project decisions related to and in collaboration with Pharmaceutical Sciences Team.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor's degree in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 5+ years relevant industry experience
• Master's degree in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 3+ years relevant industry experience
• PhD in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 3+ years relevant industry experience
• In depth knowledge and skills of testing method development, in-process testing and GMP release testing for biologics or synthetic molecules (small molecules and/or oligonucleotides) under cGMP.
• Have developed expertise in multiple areas of analytical technology and demonstrate an in-depth working knowledge of program strategy. Experienced with working on development assets and with various regulatory agencies
• Experience with method development, validation (phase appropriate and ICH), and transfer; Ability to design and direct analytical strategy to meet CMC project objectives
• Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects across businesses and the globe.
• Experience in writing regulatory documents with sound knowledge of current cGMP

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.

Locations

Fujisawa, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time