Principal Scientist or Associate Scientist, Analytical Controls Japan, Analytical Controls Full-time

Job Title

Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives – we're looking for like-minded professionals to join us.

Takeda is the number one pharmaceutical company in Japan and a global industry leader –we are united by our four priorities (Patients, Trust, Reputation, and Business) and our shared values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. Takeda-ism is more than just a word. It's a belief and a mindset which guides our decisions, behaviors, and interactions. It's how we strive to work and live, every day.

Objectives/Purpose

• Contribute proactively to pipeline development and strategic discussion as a cross functional team member to plan/coordinate and evaluate impact of decisions across Pharm Sci functions and other development functions.

• Independently lead and manage the external GMP testing activities and shelf-life setting strategies for drug substance and drug product to deliver the high quality and innovative medicines to patients through the strategic planning and execution including complex problem solving, like laboratory investigations and technical management of external vendors, for pharmaceutical development until the commercial launch.

• Oversight and approval of analytical method validation, verification and transfer documents for testing readiness at the GMP testing site.

• Prepare and coordinate completion of relevant CMC sections of regulatory documents and reports within expertise for regulatory submission.

• Required to be recognized as an expert of analytical GMP compliance such as data integrity, GMP documentation and management, statistics for stability and shelf-life predictions, GMP regulated information management systems (LIMS, DMS) based on solid understanding of industry standards on analytical methods for synthetic molecules (i.e. small molecules, Oligo nucleotides and Peptides) and biologics.

Accountabilities

• Manage GMP testing and relevant activities for investigational products (i.e. drug substance and drug product) to generate Takeda official CoA and stability outcomes including leading laboratory investigations.

• Strategy and oversight of review/approval of method validation and transfer documents.

• Manage external testing partners such as CTOs, CDMOs and CROs to be compliant under GMP and meet the development timelines.

• In collaboration with commercial functions, handover of the product knowledge obtained in GMP testing throughout development stage and align with PPQ/post-approval stability study designs.

• Build and maintain good partnership with internal / external partners and stakeholders 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 validation, stability studies and Analytical Quality by Design (QbD).

• Deliver high quality and reliable data for patient safety during clinical trials 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.

• Contribute to establishing and managing operational processes with the department/function, including harmonization and standardization Analytical Controls and Analytical Development (but also PharmSci) processes in collaboration with Quality partners.

• 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 GMP compliance, driving pipelines and relevant regulatory knowledge 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) under cGMP.

• Has 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, with various regulatory agencies and GMP Audit (Experience in Health Authority Inspections preferred.)

• Knowledge and experiences on each of industry standard analytical techniques to consolidate those outcomes and interpret them to product quality, as well as working in a lab setting. (LC, dissolution, KF, particle size analysis, XRPD etc.)

• Experiences with method development (nice to have), validation (phase appropriate and/or ICH), and transfer; Ability to review a design and analytical strategy to meet CMC project objectives.

• Ability to analyze a wide variety of information and data with capabilities of statistics and in silico modelling 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.

• Excellent command of English (oral and written) and Japanese.

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