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Head of Viral Vector

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07 MAY '24: Currently we are seeking an experienced and visionary Head of Viral Vector to lead the growth and development of our Viral Vector team. As the Head of Viral Vector, you will be responsible for overseeing the development and GMP manufacturing of our clients' Cell and Gene Therapy products.

Details

Biotechnical

Leiden - Netherlands

40 uur per week

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Zo maak jij het verschil

As Head of Viral Vector, you will be responsible for the development and GMP manufacturing of Cell and Gene Therapy products. The Viral Vector department will have two operational modes - a non-GMP facility for development and a GMP facility for production. in this your key responsibilities include to: Ensure the Viral Vector department operates efficiently and maintains high data analysis and reporting standards; Provide strong leadership, coaching, and mentoring to the Viral Vector team; Ensure compliance with GMP guidelines, including handling deviations, change controls, CAPAs, and audits; Support business development, client communication, and project proposal design; Optimize department operations and drive continuous improvement; Maintain high standards of data analysis, reporting, and safety practices; Motivate, coach, and develop the Viral Vector team to reach performance goals; Evaluate personnel and co-create training plans for personal development; Ensure GMP compliance in work practices and documentation; Support deviation investigations, change controls, CAPAs, and audits; Establish effective communication and escalation processes; Lead complex internal and external meetings as a subject matter expert; Support business development activities.

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Wat jij mee brengt

To excel in this role you, at least need a Ph.D. in biomedicine, biochemistry, biotechnology or similar. Together with this you bring along:
  • At least 10 years relevant work experience in the Viral Vector field;
  • Experience with Viral Vector products based on Adeno-Associated Virus (AAV) or Lentivirus (LV);
  • Experience in executing Viral Vector GMP and development projects;
  • 5 years of progressive managerial experience and demonstrated experience leading experts from various fields relevant for the Viral Vector projects;
  • Knowledge of GMP standards and ATMP regulations;
  • Experienced in writing GMP documentation including SOPs, policies, Risk Assessments, CAPA’s and other manufacturing related documents;
  • Hands on experience with the relevant platforms, processes and systems used;
  • Familiar with the CMC (Chemistry, Manufacturing and Controls) requirements throughout the drug development life cycle;
  • Strong verbal and written communication skills in English.

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Jouw voordelen

Besides the opportunity to build and thrive in an ATMP-focussed environment, this company offers:
  • Competitive salary and benefits package
  • 8% holiday allowance and 13th-month pay
  • 25 days of paid time off per year, and full-time is 36 hours
  • Commuting allowance and fully reimbursed public transport
  • Non-contributory pension scheme
  • Flexible employment conditions
  • Opportunity to work in a modern, inspiring, and collegial environment

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