Head of CMC Development (Advance Therapy + Phase III)

Oct 15, 2020
Nov 14, 2020
Alejandro Serafin Lopez Perez
Jobseeker Type
Organization Type
Contract Type
Full Time

Head of CMC Development (Advance Therapy + Phase III)

Our client holds a manufacturing site in the south of Spain and currently is seeking for a Head of R&D to take over the activities related to the strategy in Manufacturing, Quality Control and R&D.

Some of the highlights of the main responsibilities of this role are:

  • Operations management for manufacturing operations and line management responsibility for the managers of Manufacturing, R&D and QC groups
  • Oversight of development, maintenance and regulatory compliance of cell therapy GMP manufacturing facilities in Seville and manufacture of cell and gene therapies for clinical trials in phase III
  • Development of and execution of a strategy plan for CMC development and integration in integrated development plan
  • Design of manufacturing processes, QC assays and other product characterisation methods
  • Project management of CMC process development for commercial manufacturing of REX-001 and other cell and gene therapies including process closure and integration of electronic quality management systems (eQMS) and process tracking systems
  • Development and integration of eQMS and administration systems for application in GMP manufacture
  • Characterisation and of cell therapy attributes and process characteristics relevant to the biological activity and quality of cell and gene therapies
  • Management of technology transfer of REX-001 manufacturing to additional facilities in North America
  • Oversight of preparation of CMC sections for regulatory filings
  • Establishment and management of external relationships for project partnerships in cell and gene therapy CMC development and manufacture
  • Drafting, editing and updating of regulatory materials including IMPD, briefing packages etc.
  • Documentation of projects, processes, technical findings in internal documents and manuscripts for publication in scientific journals

The requirements for this position are:

  • Degree in relevant cell biology, biochemistry, immunology, pharmacy, pharmaceutical development or related discipline
  • Minimum 10-year experience of pharmaceutical manufacture in a regulated GMP environment
  • Extensive experience with the GMP manufacture of cell and gene therapies
  • Experience of project management of CMC development preferably for cell and gene therapies
  • Extensive experience of documentation of technical findings
  • Experience in line management of laboratory and/or manufacturing personnel
  • Creative problem-solving abilities in CMC development
  • Experience of interaction with local and international pharmaceutical regulators (especially EMA and FDA)
  • Experience of managing technology transfer of complex pharmaceutical manufacturing processes
  • Track record of publications in international scientific or technical journals and presenting at scientific conferences
  • PhD in relevant discipline
  • Fluency in written and spoken English, Spanish language to intermediate level or above

What's offered:

  • Permanent position in a fast growing bio-tech company
  • Dynamic work environment
  • Management position taking responsibilities for the activities of two manufacturing sites
  • Competitive salary based on experience
  • Relocation package included if it's required
  • Other benefits

Does it feel like the role that you've been looking for? Forward us your updated CV at a.lopez@nonstop-recruitment.com or call us at: +41 43 508 0817 Extension: 3347 and ask for Alejandro Lopez to talk more about it.

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