Senior External Manufacturing Manager Technology Fill
vor 4 Wochen
We are seeking a highly experienced External Manufacturing Manager Technology Fill & Finish to join our team at Talentor Austria GmbH. As a key member of our operations team, you will be responsible for leading daily technical activities for commercial manufacturing, including technical reviews of EP process change requests and deviation reports.
Key Responsibilities:
- Manage projects related to commercial vaccine production, including process improvements, capacity increases, and new product introductions
- Conduct technical evaluations such as Deviations and CAPAs
- Develop and implement production and product strategy, translating ExM/product strategy into executable technical plans
- Oversee technical risk management and product lifecycle, including tech transfer and product launches, ensuring development and adherence to technical risk management plans
- Identify and resolve technical issues, troubleshoot, and lead problem-solving efforts
- Manage Change Control, providing technical impact assessments for change controls and product complaints
- Review and approve documents like MBRs, risk assessments, qualification protocols, and CMC documents
Requirements:
- University degree
- Several years of experience in large-scale commercial pharmaceutical manufacturing
- Profound knowledge in formulation and process development of sterile injectable products with hands-on experience in a plant setting
- Experience working with external suppliers or within a cross-functional, matrix organization is desired
- Leadership skills: capable of leading and guiding others, especially in cross-functional teams
- Hands-on, results-oriented and dynamic team player with extensive project management skills
- Understanding of cGMP, post-approval changes, ICH guidelines and regulatory validation
- Fluent in English, German is a plus, willingness to travel
About the Company:
Talentor Austria GmbH is a successful and growing company with an attractive product portfolio and a promising pipeline. We offer a diverse range of tasks in a newly created position and the possibility to actively shape the company's success.
Compensation:
The compensation for this position consists of a gross annual salary of € 70.000 (excluding bonus). Overpayment is possible and depends on your qualifications and work experience.
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Vienna, Österreich Talentor Austria GmbH VollzeitJob Title: Senior External Manufacturing Manager Technology Fill & FinishJob Summary: We are seeking a highly skilled Senior External Manufacturing Manager Technology Fill & Finish to join our team at Talentor Austria GmbH. As a key member of our commercial manufacturing team, you will be responsible for leading daily technical activities, managing projects,...
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Vienna, Österreich Talentor Austria GmbH VollzeitJob SummaryWe are seeking a highly skilled External Manufacturing Manager Technology Fill & Finish to join our team at Talentor Austria GmbH. As a key member of our organization, you will be responsible for leading daily technical activities for commercial manufacturing, including technical reviews of EP process change requests and deviation reports.Key...
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