(Senior) External Manufacturing Manager
vor 1 Monat
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, Shigella and Zika.
Responsibilities
We are currently looking for a (Senior) External Manufacturing Manager (m/f/d) to join our team in Vienna. In detail you will be working on tasks such as:
Single point of technical contact towards assigned External Partner’s 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 sitesRequirements
Demonstrated ability and expertise in supporting day-to-day activities related to functional technical operations in a cGMP manufacturing setting 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 an add-on, willingness to travelBenefits
Open, appreciative company culture with innovative spirit and attractive assignments International surrounding with flat hierarchies Good team spirit in a strong and highly motivated team Wide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events, myClubs, full access to LinkedIn Learning, ...Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € ,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.
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