非公開
【Objectives】
・Provide technical expertise within the GMSci Japan organizations relating to manufacturing technology and sciences for drug product manufacturing.
・Serves as the SME for leading major technical transfer or validation projects relating to new product introduction or life cycle management of existing products
・Provides leadership for regulatory interactions including CMC content for dossiers
・Ensures process knowledge is shared and leveraged across sites and functions
・Serves as Takeda’s global DP SME for issue resolution as needed
【Accountabilities】
・Serves as Takeda’s expert on small molecule OSD or parenterals process and technologies
・Lead the following activities, along with Pharmaceutical Sciences and/or Operation Units:
-Drug Product Manufacturing Process Characterization,
-Technology Transfer from/to both CMOs and/or internal manufacturing sites,
-Drug Product manufacturing and packaging process validation
-Serves as the experts for deployment as rapid response teams to serve all local manufacturing sites and Operating Units
・Manage projects within Takeda product portfolio, both development and commercial, to support Global Manufacturing Sciences (GMSci) Japan and GMSci DP and Packaging Science activities
・Implement strategies for the continuous improvement on the manufacturing of Marketed Products (a.k.a. matured products) in the late phase of the product life cycle
・Implement the manufacturing strategy for key Takeda products at internal manufacturing network and CMOs
・Acccountable for successful collaboration with
‐Other functions within GMS
‐Manufacturing Operating Unit Site leads
‐Local Technical Services functions
‐Pharmaceutical Sciences counterparts
‐Other key functional groups such as Global Quality, Regulatory CMC, etc.
・Provides above leaderships for multiple Takeda key products.
【Dimensions and Aspects】
Technical/Functional (Line) Expertise
SME for Takeda drug product manufacturing organization and network
In depth and broad understanding of drug product manufacturing technologies for solid oral dosage form or injectable products
Knowledge of industry’s best practice and innovative/emerging technology with manufacturing of drug products.
Leadership
Ability to influence within the organization, specifically with Pharmaceutical Sciences, GMS Operating Units and CMOs to drive decisions, alignment, and conflict resolution for complex cross-functional issues
Effectively communicate and implement innovative and emerging technology for drug product within the Manufacturing Sciences organization.
Able to communicate and influence decisions of Pharmaceutical Sciences development organization
Decision-making and Autonomy
Able to independently make complex and key decisions impacting drug product manufacturing organizations.
Interaction
Active engagement with development product implementation prior to commercialization to ensure successful commerciallization of key Takeda products.
Actively partner with local Manufacturing Sciences lead to ensure consistent application of best techology practices across Takeda network
Innovation
Ensures process knowledge sharing across sites and functions for effective management of products
Maintain current industry leading technology knowledge, scientific approach and regulatory strategies
Ability to drive and implement of innovative technology at Local Technical Services organizations
Complexity
Manages with a matrix of reporting lines and across functional areas
Provides leadership to drive highly complex projects including that span multiple sites and products
・部門内外あるいは国内外の別拠点等、入社後も社内公募で様々なキャリアの方向性が選べます。
・幅広い製品、技術分野に携われ、経験を拡張できる（無菌、原薬、固形、注射、ワクチン など）。
当社程の製品群ならびに開発～生産まで全工程を同一拠点にて行っている企業は珍しい。