Principal or Associate Scientist, Analytical Development Japan (Late Stage), Pharmaceutical Sciences Full-time

Job Title

Independently 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.

Objectives/Purpose

• Independently 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.
• Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents and reports within expertise for regulatory submission.
• Required to be recognized as a subject matter expert in analytical technologies such as dissolution, chromatography, MS spectrometry, other spectrometries for synthetic molecules (Small molecules, Oligonucleotides, Peptides) with the capabilities of statistics, data sciences and in silico modeling for analytical development, 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.
• In collaboration with commercial functions, develop and implement strategies to control quality of drug substance and drug products based on the current GxP regulations.
• 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.
• 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 oligonucletides) 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 late-stage assets and with various regulatory agencies
• Knowledge of analytical techniques with advanced experience in multiple techniques for synthetic molecules such as LC, dissolution, KF, 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.
• 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
• Proven external scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts

Locations

Fujisawa, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time