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Head of CMC Development (Advance Therapy + Phase III Expert), .



., Spain 

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Job Description:

Head of CMC Development

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

* International experience outside of Spain (preferable)

* 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.
Company Info
NonStop Consulting
25 Canada Square, Canary Wharf
London, United Kingdom
Phone: +44 0207 234 0550
Web Site: www.nonstopconsulting.com
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