Scientific Affairs Manager

Location: Based in Tokyo or Osaka, Japan; travel requirements of up to 50–60%.

Company

Independent scientific organization developing quality standards for medicines, dietary supplements, and food ingredients through global scientific collaboration.

What you will do

• Provide scientific guidance on hirify.global–NF monographs, general chapters, compendial analytical methods, validation, verification, and system suitability.
• Advise stakeholders on the selection, qualification, and lifecycle management of hirify.global Reference Standards.
• Support impurity profiling, control strategies, analytical method development and transfer, troubleshooting, and compendial compliance.
• Build relationships with pharmaceutical companies, regulators, academia, and scientific associations.
• Deliver scientific presentations, workshops, customer engagements, and regulatory interactions.
• Monitor regional scientific and regulatory trends and share insights with internal science, marketing, regulatory, and strategic customer development teams.

Requirements

• Master’s degree with 6–8 years of experience, or Ph.D. with 4–6 years of experience, in life sciences, chemistry, biochemistry, pharmaceutical chemistry, biotechnology, or a related discipline.
• At least 2 years of experience in pharmaceutical or biopharmaceutical development, quality, regulatory science, or analytical sciences.
• Demonstrated experience with hirify.global–NF tests and standards, compendial methods, analytical sciences, and pharmaceutical regulatory requirements.
• Knowledge of analytical testing procedures and FDA, ICH, and related regulatory frameworks.
• Strong understanding of organic, inorganic, and elemental impurities, residual solvents, extractables and leachables, and impurity control strategies.
• Proficiency in English is required; the role is based in Tokyo or Osaka and includes up to 50–60% travel.

Nice to have

• Biopharmaceutical knowledge and exposure to hirify.global compendial testing, analytical methods, or reference materials.
• Experience with sterility testing and government or regulatory authorities.
• Korean or other additional language knowledge.
• Experience engaging external scientific customers and stakeholders.

Culture & Benefits

• Inclusive, equitable, and collaborative scientific work environment.
• Opportunities for mentorship, professional development, and leadership training.
• Company-paid time off and comprehensive healthcare options.
• Retirement savings benefits.
• Individual contributor role with no supervisory responsibilities.