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Biologist, Biochemist, Biotechnologist, Biochemical Engineer as Technical Transfer Lead - Production Support, Biopharmaceuticals (m/f)

Technical Transfer Lead (m/f)
Production Support, Biopharmaceuticals, Sandoz GmbH Schaftenau

Area of Responsibility

  • Provide technical leadership for transfer projects at drug substance manufacturing site Schaftenau and liaise efficiently with involved functions (e.g. development, supply chain, QC, HSE, other sites)
  • Lead and manage all activities for assigned projects on site level for product transfers (process, technology, analytics, capacity, etc.)
  • Main responsibility to provide relevant documents (risk assessments, transfer plans and reports, etc.)
  • Support continuous process and quality improvements and ensure inspection readiness
  • Ensure that all activities are performed to current standards (cGMP, HSE, Regulatory etc.)
  • Initiate change control in system and ensure approval and closure
  • Improve Tech Transfer strategy by means of LEAN management and needs for manufacturing and view of the life-cycle of a product
  • Formulate the transfer strategy and integrate it into overall project strategy
  • Support Regulatory during filing after transfer and process validation

Qualifications

  • Education: University degree (MSc. or PhD) in Biology, Biochemistry, Biotechnology, Biochemical Engineering or equivalent degree
  • Languages: German and English fluent
  • Experience: 5+ years of professional experience in manufacturing/ manufacturing science and technology/technical development/ quality. Thorough understanding of drug substance manufacturing processes (Up- and Downstream) and experience in executing process transfers. Knowledge of quality systems and regulatory requirements across multiple health authorities. Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions). Expert in reviewing and writing (technical) programs and reports.
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 41.523,44 euros.
Contact: Cornelia Walch, Staffing Manager
Job-ID: 184584BR
Sandoz is an equal opportunity employer
While applying for the job please refer on jobvector and use the following reference number: 184584BR