技術系（機械設計・製造技術） - 製造技術・生産技術（電気・PLC制御）
技術系（機械設計・製造技術） - 生産技術（機械）
技術系（機械設計・製造技術） - プロセスエンジニア（化学）
技術系（機械設計・製造技術） - 生産技術（機械）改善
技術系（機械設計・製造技術） - プロセスエンジニア（プラント）

【職務内容】
Global Technology & Engineering Technical Partnership Operations teams (GTE TPO), is opening this position, in order to be the technical leader to Contractor Manufacturing Organizations (CMOs), based on Japan. This position requires a highlevel of independency, leadership, and great communication skills.

The GTE TPO team provides customer- facing technical oversight to Global External Supply Team through the management of complex projects such as tech transfers to 3rd party Contract Manufacturing Organizations (CMOs), and day-to-day technical support of the CMO, via the Virtual Site Oversight (VSOT) management model.

The team leads projects, as well as strategy development and implementation, which are targeted at improving cost, quality, supply reliability and revenue generation. The role will provide technical relationship oversight for the CMO site, coordinating GTE resources as needed to resolve technical issues raised to the VSOT, ensure GTE resource assignments for source change projects and complex investigations.

The VSOT lead from GTE will work closely with GTE functions and External Supply Operations teams to ensure escalation pathways are maintained, and metric data flow is timely and consistent.



How You Will Achieve It

Leads product transfers both to and between CMOs and requiring the highest level of project and program management competencies and capabilities across Japan.
Develops product transfer project estimates including Capex, OpEx; contributes technical transfer Business cases creation.
Maintains oversight on the budget during the change period; manages project risks i.e., leads the development of risk assessment and mitigations with the project team.
Leads technical changes, from definition of the change, participation in the business case development, through planning, endorsements, execution and completion.
Provides technical leadership to the Global External business, via the Virtual Site Operational Team model or similar.
Be the main technical contact with Contract Manufactures based on Japan, and other countries on Asia, when needed.
Leading technical investigations and process improvements at CMOs.
Provides timely and thorough project update reports to customers, via the established cadence and process.
Can work independently to meet key deliverables and milestones in addition to be able to effectively lead a matrix team of colleagues.
Partners with other functional areas to achieve success against business goals and objectives: Global External Supply, External Supply Quality, Procurement, Supply Chain, Planning, Finance, EHS, Regulatory, Business, Commercial.
Partners with other GTE functional areas in the completion of projects and goals.
Seeks, develops and implements improvements to GTE work processes, where appropriate.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

Must-Have

Fluent in Japanese and Advanced in English.
Skilled in Project Management, including Scheduling, experienced in Capex and Resource estimations.
Broad knowledge of pharmaceutical small molecules and sterile injectable manufacturing processes is essential (knowledge should encompass drug product, and basis of drug substance formulations as well as packaging operations). Basic knowledge of analytical methods as well as regulatory procedures & practices.
Ability to manage multiple projects across multiple contract manufacturing locations.
Demonstrated understanding of specific global regulatory requirements applied to product transfers, process improvements, and API source changes. Excellent written and verbal communication skills.
Strong analytical thinking and problem-solving ability to facilitate resolution of both business and technical issues. Well-developed interpersonal skills (leadership, integrity, team orientation, flexibility and creativity).
Minimum of a B.S. in Pharmacy, Chemistry, Chemical Engineering or a related science with at least 7 years of pharmaceutical manufacturing or project management experience. Project management skills to include experience of successful delivery of projects on schedule and to budget. Knowledge of Solid Oral Dosage, Sterile manufacturing operations and formulations
Understanding of the Pharma Drug Product regulatory environment, in particular change management.
Proven experience in working on with complex Contract Manufactures based on Asia, would be advantageous.
Experience of working in a matrixed & virtual environment

Nice-to-Have
Broadly experience on Biological operations will be a differential.
Master’s degree.
Six Sigma/Lean management certification.

■職種未経験者：不可