Principal Scientist / Associate Scientist, System Implementation (MES / LIMS / MODA), Pharmaceutical Sciences

Description

CPA (Clinical Production and Alliances)は、Pharmaceutical Scienceの一員として社内製造・試験実施機能および提携する外部の製造・試験委託機関 (CDMO / CTO) のグローバルネットワークを活用して、治験原薬(DS)、治験薬(DP)を製造することでタケダのパイプライン開発に貢献するグローバルチームです。

Responsible for introducing the manufacturing and testing control system (MES / LIMS / MODA) and various control systems and ensure the data integrity in cooperation with the manufacturing unit, testing unit, quality assurance personnel, and IT unit when starting up investigational product manufacturing facilities.

IT部門と連携し、製造および試験管理システム(MES / LIMS / MODA)および各種管理システム導入を担当し、データインテグリティを担保する

• Lead system implementation and integration within GMP Facilities Management.
• Develop operational requirements for MES / LIMS / MODA
• Coordinate with other departments and stakeholders such as system vendors and manage the schedule.
• Lead local system validation and coordination of global validation which is done by global IT team.
• Responsible for development and maintenance of master data management within the system
• Preparation / review of system-related investigational product GMP documents for investigational product manufacturing facilities
• Implementation and support of education for introduction and maintenance of various systems
• GMP施設管理内でのシステム導入およびシステム統合をリードする
• MES / LIMS / MODAの運用要件の策定
• ITチームが実施するグローバルバリデーションの調整とローカルシステムバリデーションをリードする
• GMP文書の作成 / 確認
• 5+ years of experience in manufacturing and quality control of drugs and drug candidates.
• Experience as a system engineer or project management is preferred
• Experience for participation in GMP digitization projects, promoting and introducing digitization
• Basic knowledge on pharmaceutical quality control / manufacturing control system
• Experience in manufacturing of drugs or drug candidates
• Experience participating in cross-functional development programs / projects.
• Business level of both English and Japanese
• 5年程度以上の業務経験を有する
• GMPのデジタル化プロジェクトへの参画、デジタル化の推進・導入経験
• TOEIC700点程度以上が望ましい
• web会議に対応できる方

1回程度の在宅勤務も可能な職場です

Empowering Our People to Shine

Takeda 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