Vaccine Manager MS&T Drug Products
vor 1 Woche
We are seeking a highly motivated and experienced professional to join our team as a Manager of Vaccine Manufacturing Operations. In this role, you will be responsible for providing technical expertise and leadership for the formulation and fill-finish of our Tetravalent Dengue Vaccine, as well as the manufacturing of our Diluent.
Key Responsibilities- Provide technical support to commercial manufacturing to ensure productivity, quality, and compliance goals are met.
- Ensure robust manufacturing and analytics processes are in place to support product goals for safety, compliance, productivity, and supply.
- Support further development and troubleshoot management of quality systems, including change controls, deviations, and CAPA management.
- Work with Development, Manufacturing, Engineering, and Business Excellence teams to plan and manage process improvements, scale-up, technical transfers, and life-cycle management.
- Develop and implement manufacturing solutions to enhance quality, costs, and robustness of vaccine drug product and diluent manufacturing processes.
- Provide scientific and technical support to 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.
- Partner with internal and external stakeholders to communicate, escalate, and resolve program issues within Takeda and with external manufacturing partners.
- Partner with Engineering to provide process inputs for process fit assessments and to define process requirements for new manufacturing facilities.
- Work cross-functionally to develop robust proposals for scale-up and technology transfer of vaccine products, and for life-cycle management changes.
- Represent Vaccines MS&T Drug Products in cross-functional teams for engineering, qualification, and validation of new and existing vaccine and diluent manufacturing facilities, processes, and technology transfers.
- Build partnerships in the areas of engineering and process equipment to drive awareness of new technologies for best-in-class manufacturing operations.
- Bachelor or Master degree with solid experience in start-up, tech transfer, and/or sustaining cGMP for drug product processes in manufacturing or biopharmaceuticals.
- Experience working with live viruses vaccines preferred.
- Scientific and technical knowledge regarding formulation, filling, freeze-drying, and visual inspection unit operations in biopharmaceutical manufacturing, including single-use technologies.
- A self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of structured product development.
- Proven ability to work with efficiency across multiple project teams and business functions in a matrix environment.
- Able to lead and manage technical teams, serve as a partner, and influence others.
- Demonstrated cross-functional team experience.
- Willingness to travel.
- Work proficiency in English is mandatory, German and other languages knowledge is a plus.
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.
About the Benefits- Attractive and competitive salary.
- Open-minded and modern working environment.
- Hybrid working model.
- 30 vacation days.
- Company pension plan.
- Further education and training.
- Commuting allowance.
- Attractive Relocation Package including brokerage fees.
- Subsidized canteen.
- Subsidized sports programs.
- Disability insurance.
- Long-term account with various possible uses.
- Employee discounts.
- Employee Stock Purchase Plan.
- Company accident insurance.
- Performance-related bonus.
- Trusted working hours.
- Employee Referral Program.
- Deferred compensation as desired.
- Global Wellbeing Program.
- Interactive online courses for employees' children.
- Employee Recognition Program.
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Manager Vaccines MS&T Drug Products Specialist
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Singen, Baden-Württemberg, Deutschland Takeda VollzeitAbout the Role:Takeda is seeking a highly motivated and experienced professional to join our team as a Manager Vaccines MS&T Drug Products Specialist. 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.Key Responsibilities:Provide...
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