Principal or Associate Scientist, Analytical Development Japan, Pharmaceutical Sciences Full-time

Job Title

Please note this job requires business level Japanese in speaking, writing, and reading.

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（＝）（Patient）（Trust）（Reputation）（Business）

OBJECTIVES/PURPOSE

• Independently lead the development of analytical methods, qualification and validation for drug substance and drug product to timely deliver the appropriate clinical trials materials through the strategic planning and execution based on phase appropriate 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.
• In collaboration with Research, developability assessment of candidate molecules through physicochemical profiling, solid form optimization & characterization, biopharmaceutical assessment and stability assessment with in silico platform are provided.
• Required to be recognized as a subject matter expert in analytical characterization such as spectroscopic analysis, X-ray analysis, MS spectrometry, Thermal analysis and other specrometries for synthetic molecules (Small molecules, Oligonucleotides, Peptides) with the capabilities of statistics, data sciences and in silico modeling for physicochemical characterization, stability prediction and GI absorption / pharmacokinetic modeling etc.

ACCOUNTABILITIES

• Develop and validate ICH compliant and reliable analytical methods for drug substance 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 across global and cross cultural environments.
• 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.
• Execute developability assessment for candidate compounds based on physicochemical profiling, solid form optimization & characterization, biopharmaceutical and stability assessment with in silico platform and in collaboration with Research Team.
• Prepare and present comprehensive technical and/or project reports and formal presentations to a full range of internal / external audiences.
• Lead and contribute to strategic initiatives and activities within the organization to increase productivity of pipeline development and technical capabilities
• Participate in defining and coordinating department priorities and strategies
• Recognized as a technical expert across Pharm Sci functions
• Serve as a technical resource or mentor for junior staff and leverage expertise in laboratory technology as a functional resource/trainer

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor's degree in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 7+ years relevant industry experience
• Master's degree in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 5+ years relevant industry experience
• PhD in Chemistry, Engineering, Biology, Analytical Chemistry or related Pharmaceutical Science and 3+ years relevant industry experience
• Extensive experience in CMC pharmaceutical development for drug substances and drug products of synthetic molecules (small molecules and/or oligonucleotides, peptides) under cGMP
• Have good attitude on continuous learning and adaptability to evolving scientific domains and global development practices.
• Have developed expertise in multiple areas of analytical technology and demonstrate an in-depth working knowledge of program strategy. Experienced with working on early-stage assets.
• Technical knowledge and skills of solid form screening and characterization, biopharmaceutical assessment and physicochemical profiling of candidate molecules.
• Knowledge of analytical techniques with advanced experience in multiple techniques for synthetic molecules such as LC, dissolution, spectroscopy, particle size analysis, XRPD etc.; Able to work in a lab setting and independently interpret results of complex experiments and integrate data produced by other disciplines
• Experience with method development, validation (phase appropriate and ICH), and transfer; Ability to design and direct analytical strategy to meet CMC project objectives
• Ability to analyze a wide variety of information and data with capabilities of statistics, data sciences and in silico modeling to make management decisions regarding potential risks associated with product quality and regulatory compliance, including the ability to quickly abstract key insights and apply them to new or unfamiliar contexts.
• Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects across businesses and the globe while adapting effectively to different cultural and organizational contexts.
• Experience in writing regulatory documents with sound knowledge of current cGMP
• Proven external scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts

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