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Head MS&T

 
 
 
Head MS&T

Currently we’re looking for

1

Head MS&T




We are waiting just for you!

What will you do?

  • Establish and maintain MS&T organizational capability and governance processes to
  • Lead validation and ensure execution of Validation Master Plans and continuous data monitoring/trending
  • Keep technology strategies to current and future standards in partnership with key functions (Production, Development, QA/Regulatory, Business)
  • Execute product remediation of technical issues and provide technical support
  • Product Stewardship: full accountability and oversight of product related technical process and quality aspects to ensure manufacturing of robust products (Lifecycle Management of a production process)
  • Technical Stewardship: Oversight and definition of processes and standards to maintain existing technologies and implement new innovative technologies for manufacturing including the development of requirements for new equipment vTechnical Transfer Leadership: Lead technical transfers of products within and between sites as well as from development into large scale facilities
  • Process Support Leadership: Ensure end-to-end oversight of process performance and early initiation of corrective actions based on monitoring of product/process parameters. Ensure current process technical issues are solved in a timely manner, drive implementation of CAPAs etc.
  • Validation Leadership: Own and write VMP. Provide governance for site validation activities. Perform scientific evaluation/risk assessments of APR/PQR, CPP/CQA, CPV

What do we expect?

  • 5-8 years of experience in manufacturing/manufacturing science or technology/technical development
  • Thorough understanding of manufacturing processes (Up- & Downstream) and related process equipment
  • 2-5 years of experience in executing process validation, having led and managed validation projects
  • Expert in reviewing and writing technical reports
  • Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
  • Strong in leadership and people management, with ability to build up and develop the team
  • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
  • Fluent in English, willing to learn Polish language
  • Flexible and adaptable

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