Job Description

• Deliver scientific application support for endotoxin detection assays and related workflows, including method development, assay troubleshooting, and validation support.
• Provide training and consultation to laboratory personnel on assay design, instrument operation, and software use, ensuring compliance with regulatory and quality standards.
• Perform installation, configuration, and software updates for instruments and associated applications, ensuring readiness for routine use.
• Execute basic troubleshooting (software or application-related) and escalate hardware issues to FSEs or arrange shipment to the factory for repair.
• Support application-level troubleshooting for larger platforms, collaborating closely with FSEs as needed.
• Conduct IOPQ, validation assistance, and customer-specific QA documentation in line with the Quality Manual and industry regulations.
• Act as the first point of escalation for scientific and application-related customer concerns, ensuring issues are resolved efficiently and knowledge is shared.
• Collaborate with distributor and application teams: deliver training, assess capability, and review customer service quality and application outcomes.
• Maintain accurate records of customer support activities (e.g., protocols, troubleshooting notes, SFDC entries).
• Develop and update scientific protocols, training materials, and troubleshooting guides to support customer success and team knowledge-sharing.
• Provide mentoring and knowledge transfer to new or junior FAS team members.
• Coordinate travel and manage application support activities in assigned territories.
• Maintenance of quality systems and cGMP compliance for the business by ensuring compliance with processes, procedures and instructions for all activities in which the individual participates, including MHLW (Japan) regulations where applicable. Helps identify & resolve account sites operating outside of guidelines.
• Utilize of Tokyo Demo-lab for demonstration, training program and technical trouble shooting.
• Communication with local authority, study group, KOL for updated direction of Japanese Pharmacopoeia.
• Perform other duties as assigned.

Qualifications

• Degree :Master or Phd

• Field of Study：Biology

• English：Business Fluent

• 5+ years of laboratory experience, with hands-on use of analytical instruments and scientific software applications.
• Laboratory skills for pipetting, operation of endotoxin testing assays, microplate readers, and automated liquid handling systems and software.
• Understanding of regulatory frameworks and quality systems in pharmaceutical, medical device, environmental, and dialysis industries.
• Familiarity with installation and validation of laboratory instruments and software applications.
• Proficiency in software operations such as configuration, updates, and application troubleshooting.
• Basic mathematical ability for endotoxin calculations (release limits, dilutions, allowances per regulatory guidelines).
• Communication (both written and verbal) in both Japanese and English with ability to articulate key technical concepts; listening skills, independent and self-directed
• Excellent communication and presentation skills, capable of translating technical concepts into practical guidance for laboratory teams.
• Proficiency in Microsoft Office and CRM tools.
• Better to have comprehensive knowledge of regulatory guidelines.
• Maintains a valid driver’s license and Passport with in company guidelines.
• Strong planning and organizational skills, with ability to travel independently as required.
• Management of expenses and expense reporting.