Head MS&T Biologics.

Job ID: 10910

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Discipline
Quality/Production
Type of employment
Festanstellung
Company

Our Client is a biopharma company with cutting-edge facilities. Operating across international centers specialized in clinical manufacturing and commercial scale production. Our client provides expertise and facilities from cell line development over process development, API production to fill & finish for partners and in-house biological pipeline. The leading service-provider for biologics.

Responsibilities

The Head of Manufacturing Science and Technology will ensure that products/production processes are validated and remain in constant state of control including a system of continuous data monitoring and trending as well as that manufacturing processes are optimized and technical support is taken care of. He will trigger post launch development for process optimization, provide future technology strategy and is complementary responsible for implementing and driving CI/IQP (Innovation Quality, Productivity) strategy.


In detail:

  • Establish and maintain MS&T organizational capability and governance processes to ensure products and technologies are within validation and current technology standards
  • Lead validation and ensure execution of Validation Master Plans and continuous data monitoring/trending
  • Execute product remediation of technical issues and provide technical support
  • Keep technology strategies to current and future standards in partnership with key functions (Production, Development, QA/Regulatory, Business)
  • Establish a responsible function respectively system for (critical) material qualification of product contact material
  • Ensure technical training of MS&T population
  • Build-up MS&T team
Requirements
  • Thorough knowledge of the scientific principles and concepts in biochemical & pharmaceutical sciences, especially manufacturing of parenteral products
  • Lean / Six Sigma training and experience
  • Good interpersonal skills and demonstrated net-working capacities allowing to effectively work in a matrix organization and a multi disciplinary team environment
  • Good understanding of cGMPs, industry and regulatory standards and guidelines, strong ethical foundation and a sound compliance understanding
  • Academic degree in science (biotechnology, biochemisty, process engineering)
  • 5-10 yrs working in the field of cell culture development or production
  • Fluent English language
Benefits
  • An opportunity to build and shape an organization according to your ideas
  • Internationally competitive compensation & benefits
Region
Europa