Technical Lead for Commercial Vaccine Production

Vor 3 Tagen

Wien, Wien, Österreich Talentor Austria GmbH Vollzeit

Job Overview:

We are seeking a highly experienced External Manufacturing Manager Technology Fill & Finish to lead daily technical activities for commercial manufacturing and drive the success of our company.

Key Responsibilities:

  • As the single point of technical contact, you will manage relationships with external partners and internal departments to ensure smooth operations at manufacturing sites.
  • You will lead daily technical activities for commercial manufacturing, including reviewing process change requests and deviation reports to ensure compliance with regulatory requirements.
  • Your expertise in project management will be essential in overseeing projects related to commercial vaccine production, including process improvements, capacity increases, and new product introductions.
  • You will conduct thorough technical evaluations, such as deviations and CAPAs, to identify and resolve technical issues.
  • Developing and implementing production and product strategy will be a key responsibility, translating ExM/product strategy into executable technical plans.
  • You will oversee technical risk management and product lifecycle, ensuring development and adherence to technical risk management plans, including tech transfer and product launches.
  • Identify and resolve technical issues, troubleshoot, and lead problem-solving efforts to drive process improvements.
  • You will 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 to ensure compliance with regulatory requirements.

Requirements:

  • You must have a university degree and 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 is required.
  • Experience working with external suppliers or within a cross-functional, matrix organization is desired.
  • Leading and managing cross-functional teams on a project basis is essential.
  • You must be a hands-on, results-oriented, and dynamic team player with extensive project management skills.
  • Understanding of cGMP, post-approval changes, ICH guidelines, and regulatory validation is necessary.
  • Fluent in English, German is a plus, and willingness to travel is expected.

Compensation:

We offer a gross annual salary of EUR 70,000 (excluding bonus), with the possibility of overpayment based on qualifications and work experience. Our company offers a diverse range of tasks in a newly created position, the possibility to actively shape the company's success, and a successful and growing company with an attractive product portfolio and a promising pipeline.

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