Principal Scientist, Synthetic Molecules Characterization & Attribute Sciences, Analytical Development

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Job Description

About Takeda

”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

Objectives / Purpose

Independently leads characterization activities of synthetic-molecule through the strategic planning and execution based on phase appropriate pharmaceutical development.

Supports early-stage developability assessment and candidate selection in collaboration with Research by physicochemical, solid-state characterization, solid form study, and product-relevant understanding.

Contribute to pipeline development and strategic discussion to evaluate impact of decisions across PharmSci functions and other development functions through physicochemical, solid state, structural characterization, solid form study, and technical investigations.

Required to be recognized as a subject matter expert in analytical characterization such as spectroscopic analysis, X-ray analysis, NMR, MS spectrometry, Thermal analysis and other spectrometry for synthetic molecules (Small molecules, Oligonucleotides, Peptides) with the capabilities of data science, in silico modeling for molecular characterization, stability prediction and GI absorption / pharmacokinetic modeling etc.

Accountabilities

·       Lead developability assessments for candidate molecules in collaboration with Research and Pharmaceutical Sciences partners.

·       Generate and integrate physicochemical, solid-state, stability, and biopharmaceutical evidence to identify development risks and enable candidate selection.

·       Translate characterization findings into clear recommendations for candidate selection, developability risk mitigation, solid-form strategy, and formulation direction.

·       Apply solid-state and material techniques, such as XRPD, DSC, TGA, DVS, microscopy, spectroscopy, particle characterization, and related methods; expertise in every technique is not required.

·       Characterize impurities including nitrosamines and mutagenic impurities and contribute scientific evidence to multidisciplinary risk assessments.

·       Lead or support investigations of unexpected analytical observations, material variability, degradation, stability trends, manufacturing events, and product-performance concerns through orthogonal techniques such as NMR, MS, spectroscopy, chromatography, diffraction, thermal analysis, and microscopy.

·       Use fit-for-purpose statistics, data visualization, predictive tools, and in silico / AI-enabled approaches to strengthen experimental design, molecular and material understanding, stability assessment, and biopharmaceutical risk evaluation.

·       Collaborate closely with Research, DMPK, Drug Safety, Process Chemistry, Formulation Development, and other partners as appropriate.

·       Provide scientific oversight of CROs and external laboratories, including study design, protocol / report review, progress monitoring, data evaluation, and resolution of technical issues.

·       Prepare and present study plans, technical reports, risk assessments, scientific recommendations, and development documentation for internal and external partners.

·       Contribute characterization content and scientific justification for regulatory documents and responses as appropriate to project phase and role.

·       Lead or contribute to initiatives that improve scientific quality, productivity, consistency, knowledge reuse, and technical capabilities across the organization.

·       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

·       Demonstrated ability to independently design studies, integrate data across disciplines, and communicate actionable scientific conclusions.

·       Technical knowledge and skills of solid form study, biopharmaceutical assessment and physicochemical profiling of synthetic molecules.

·       Understanding of pharmaceutical development and the relationship among candidate properties, material attributes, formulation, process, stability, biopharmaceutics, and analytical strategy.

·       Strong scientific judgment, problem-solving, technical writing, presentation, collaboration, and stakeholder-influence skill.

·       Experience with in silico tools, predictive modeling, statistics, data science, automation, or AI-enabled scientific workflows.

·       Knowledge of analytical techniques with 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.

·       Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects across businesses and the globe. 

·       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