Project Manager

1 week geleden

Leiden, Zuid-Holland, Nederland Oxford Global Resources Voltijd

We are looking for an enthusiastic Project Manager to join the EU Site Management team in Leiden as a contractor.

Our client is a dynamic and rapidly growing Biotech company that is embarking on an exciting phase of expanding and diversifying its pipeline. This journey begins with a focus on oncology, particularly CAR-T cell therapy, a groundbreaking approach to treating various types of cancer.

Our client champions a unique, decentralized model for cell therapy manufacturing, with the potential to provide efficient treatment within 7 days, simplifying logistics and improving patient outcomes significantly.

The Project Manager's role involves assessing pre-selected manufacturing partners (CDMOs or blood banks) from a technical standpoint. This includes evaluating the facility's suitability and relevant licenses to support the company's Decentral Manufacturing concept. Furthermore, the Project Manager will oversee the commencement and technology transfer processes.

Key Responsibilities:

  • Participate in site selection from a Tech Ops perspective, involving assessment of manufacturing facilities and partner capabilities
  • Evaluate GMP readiness, ensuring all required licenses are in place or obtained
  • Provide necessary information for informed site selection decisions
  • Lead project management during start-up and tech transfer phases
  • Coordinate implementation of licenses and equipment deployment
  • Develop and maintain tech transfer plans
  • Facilitate Project Team Meetings and report project status to the management team
  • Monitor manufacturing operations and facilitate necessary changes
  • Write procedures, deviations, change controls, and CAPAs as needed

Requirements:

  • MSc or Ph.D. in life sciences, biotechnology, or a related field
  • Demonstrated Project Management skills and tools proficiency
  • Experience with Contract Manufacturing Organizations in the pharmaceutical/biotech industry
  • Knowledge of CMC requirements for ATMPs in clinical phases
  • Familiarity with GMP, ICH guidelines, and regulatory standards
  • Understanding of Point-of-Care manufacturing site needs and digital system development
  • Excellent communication skills and adaptability to changing priorities
  • Self-motivated with a focus on quality
  • Fluency in English

Benefits:

  • Permanent contract with a competitive salary package
  • Company car included
  • On-site presence required at least 4 days per week in Leiden

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