Analytik NEWS
Online Laboratory Magazine
12/02/2022

Director Cell Line Dev&Upstream Process (m/f/d)

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What you'll bring to the role:

  • World leading cell line and upstream process development expertise
  • Extensive experience in biosimilar development through regulatory approval and commercialization
  • Cell line modification and upstream technology leadership
  • Strategic thinking
  • Ability to lead in matrix organization
Desirable Requirements:
  • Min. 10 years of experience in Cell line or Upstream process development, ideally in biosimilar development
  • Recognized expertise in the area of cell line and upstream process development and related areas. Broad scientific as well as strategic background.
  • Excellent track record of innovation, creativity, problem solving and productivity in projects.
  • Proven key contributions to development projects, marketed products, and strategic activities.
  • Critically assessing current trends and upcoming techniques for current and future applications.
  • Thorough understanding of development processes in BioTD and good understanding of development activities in some functions external to BioTD.
  • Proven track record to lead interdisciplinary and cross-cultural teams.
  • Excellent leadership skills.
  • Thorough knowledge of relevant SOP, GLP, GMP and regulations and policies.

Your key responsibilities:

  • Actively lead, initiate, and direct cross functional teams, networks and /or platforms in the field of biosimilar cell line and upstream process development and manufacturing;
  • Understand and meet individual program and customer needs and ensure all cell line and upstream development team activities are aligned with overall biosimilar development process.
  • Establish molecule specific strategies for cell line development (incl genetic modification of cell lines) and upstream process development to yield a high-quality biosimilar molecule
  • Provide scientific/technical leadership for the development of efficient and robust drug substance upstream manufacturing processes in alignment with manufacturing experts and support the transfer of upstream process to manufacturing facility
  • Initiate, lead and influence new scientific/development programs. Address complex R&D issues and collaborate across technical development line functions. Evaluate and implement new related scientific technologies.
  • Assess licensing opportunities. Collaborate with and provide guidance to external partners.
  • Drive the cell line and upstream process development unit long-term strategic plan and its implementation. Ensure current and future needs are fully met, unit projects are assigned, adequately resourced, delivered on time and in full compliance.
  • Provide comprehensive advice as a go-to person on a wide range of issues relating to cell lines and upstream processes.


» Job description


Employer:
Sandoz GmbH
Location:
83607 Holzkirchen
Temporary:
No
Part-time:
No