Manager Vaccines MS&T Drug Products (f/m/d)

at  Takeda Pharmaceutical

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JOB DESCRIPTION

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Manager Vaccines MS&T Drug Products (f/m/d)
Takeda Vaccines Business Unit is seeking a highly motivated individual for the role of Manager Vaccines MS&T Drug Products. In this role you will provide technical expertise and leadership for the Tetravalent Dengue Vaccine formulation and fill-finish as well as Diluent manufacturing activities. Supporting our external and internal manufacturing to remain operational, continuously improve, and innovate you will assume broad responsibility for tech transfers, process qualification and validation and commercial manufacturing at drug product manufacturing sites. Process package transfer, at scale studies, PPQ, process monitoring, and continuous process improvements are key focus areas for the role. High level of exposure and interaction to other functional areas supporting late-stage development, product life cycle management and commercial operations in a matrix organization is part of the role assignment.

ABOUT US:

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people, and the planet.
In Singen, around 1,300 employees specialize in the production of liquid, semi-solid and freeze-dried medicines. Singen is the only production site in the global Takeda network for the manufacture of our new dengue fever vaccine. Takeda Singen is a regionally significant employer and has been awarded the independent Top Employer certificate several years in a row. The site is characterized by its high level of diversity (e.g., more than 55 nationalities and over 40% of leaders are women), its long company history and its excellent development opportunities. The town of Singen (Hohentwiel) is located on the beautiful Lake Constance in Baden-Württemberg with a view of the Alps and close proximity to France, Liechtenstein, Austria, and Switzerland.

• Maintain scientific and technical support of commercial manufacturing to support productivity, quality, and compliance goals and improvements
• Ensure robust manufacturing and analytics, process monitoring, and knowledge management are in place to support product goals for safety, compliance, productivity, and supply
• Supporting further development troubleshoot management of quality systems (such as change controls, deviations, etc.) in collaboration with internal and external partners
• Working with Development, Manufacturing, Engineering, Business Excellence, etc., Teams to plan and manage process improvements, scale-up, technical transfers and life-cycle management
• Developing and implementing manufacturing solutions to enhance quality, costs and robustness of vaccine drug product and diluent manufacturing processes
• Providing scientific and technical support of commercial manufacturing at partners to support corporate goals for supply strategies, productivity, quality, and compliance
• Ongoing technical support for change control, deviation investigations and CAPA management as required during development and commercial manufacturing
• Partnering with internal and external stakeholders communicate, escalate and resolve program issues both within Takeda and with external manufacturing partners
• Partnering with engineering to provide process inputs for process fit assessments and to define process requirements for new manufacturing facilities
• Working cross-functionally, develop robust proposals for scale-up and technology transfer of vaccine products, and for life-cycle management changes
• Representing Vaccines MS&T Drug Products in cross-functional teams for engineering, qualification and validation of new and existing vaccine and diluent manufacturing facilities, processes, technology transfers
• Building partnerships in the areas of engineering and process equipment to drive awareness of new technologies for best-in-class manufacturing operations