Senior External Manufacturing Manager Technology Fill

vor 1 Woche


Wien, Wien, Österreich Talentor Austria Vollzeit
Take this responsible position in an international biotechnology company

Our client is a specialized player in the life science sector and a leader in his field. The company is characterized by its fast-paced environment, innovative approach, and strong team spirit.

If you are a formulation & aseptic filling expert, take your chance for the following business-critical position, which is to be filled with immediate effect:



Senior External Manufacturing Manager Technology Fill & Finish (f/m/x)

Location: Vienna

YOUR FUTURE ROLE
  • 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


JOB 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


OUR CLIENT OFFERS



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