Senior Vaccine Manufacturing Specialist
vor 1 Monat
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
Our team in Vienna is looking for a Senior External Manufacturing Manager to join us in our mission to protect people from infectious diseases. If you have experience in large-scale commercial pharmaceutical manufacturing and want to make a difference, we'd love to hear from you
About the Role- You will be responsible for leading daily technical activities for commercial manufacturing, including technical reviews of EP process change requests and deviation reports.
- You will manage projects related to commercial vaccine production, including process improvements, capacity increases, and new product introductions.
- You will conduct technical evaluations such as Deviations and CAPAs.
- You will develop and implement production and product strategy, translating ExM/product strategy into executable technical plans.
- You will oversee technical risk management and product lifecycle, including tech transfer and product launches, ensuring development and adherence to technical risk management plans.
- You will identify and resolve technical issues, troubleshoot, and lead problem-solving efforts.
- You will manage Change Control, providing technical impact assessments for change controls and product complaints.
- You will review and approve documents like MBRs, risk assessments, qualification protocols, and CMC documents.
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