Senior External Manufacturing Manager Technology Fill

vor 4 Wochen


Vienna, Österreich Talentor Austria GmbH Vollzeit
Job Summary

We 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 Responsibilities:

  • 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

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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