(Senior) External Manufacturing Manager Technology Fill

vor 1 Monat


Wien, Österreich Talentor Austria GmbH Vollzeit € 70.000

Our client is a specialized player in the life science sector and a leader in his field. Senior) External Manufacturing Manager Technology Fill & Finish (f/m/x) Location:
Vienna Single point of technical contact towards assigned external partners and internal supporting departments amongst impacted (downstream & upstream) manufacturing sites Lead daily technical activities for commercial manufacturing, including technical reviews of EP process change requests and deviation reports 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 Drive process improvements in collaboration with other departments, acting as the primary technical contact for external partners and internal departments at manufacturing sites 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 Leading and managing cross-functional teams on a project basis 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 Successful and growing company with an attractive product portfolio and a promising pipeline Diverse range of tasks in a newly created position Possibility to actively shape the company's success The compensation for this position consists of a gross annual salary of € 70.We are looking forward to receiving your application (English CV & cover letter incl.



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