MS&Tエクスパンションリード / MS&T Expansion Lead

A global pharmaceutical company seeks an MS&T Expansion Lead - RLT. The qualified individual will oversee technical activities related to site projects, ensuring timely process, technology, and product transfers.

Responsibilities:

• Achieve technical transfer milestones, including registration and launch schedules
• Ensure robust manufacturing processes that deliver critical quality attributes
• Implement cGMP-compliant analytical methods
• Maintain compliance during internal and external GMP inspections and Pre-Approval Inspections (PAI)
• Manage project costs and adhere to Capital Approval Request (CAR) budgets
• Oversee change control for process transfers, adaptations, and modifications
• Ensure availability of technical information and documentation for validation
• Act as the Single Point of Contact (SPOC) for technical transfers at the site
• Contribute to process improvement and optimisation for product transfers
• Manage training curriculum for self and direct reports

Requirements:

• Bachelor’s degree or equivalent in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field
• 5-8 years of experience in pharmaceutical manufacturing
• Comprehensive knowledge of pharmaceutical technology and project management
• Understanding of Applied Statistics, Change Controls, Chemical Engineering, Continuous Improvement Processes, Cost Reduction, Data Analytics
• General HSE Knowledge, including GDP
• Knowledge of CAPA and GMP
• Familiarity with Lean Manufacturing, Manufacturing Processes and Technologies, Process and Cleaning Validation, Risk Management and Root Cause Analysis (RCA)
• Six Sigma and Statistical Analysis
• Fluent level English; proficient in Japanese

About the Company:

One of the world’s largest providers of medical treatments for a variety of human and animal diseases. Headquartered in Europe, the company has a strong global network that is dedicated to improving people’s lives.

Keywords:

製薬, 技術, 製造, GMP, 品質, 検査, プロジェクト管理, 求人, 外資系

2054770/001