Head of CMC Development (Advance Therapy + Phase III)

Location
Andalusia
Salary
Negotiable
Posted
Oct 15, 2020
Closes
Nov 14, 2020
Ref
AL.247183.3
Contact
Alejandro Serafin Lopez Perez
Jobseeker Type
Professional
Organization Type
Corporate
Contract Type
Employee
Hours
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.

Apply for Head of CMC Development (Advance Therapy + Phase III)

Already uploaded your resume? Sign in to apply instantly

Apply




Upload from your computer

Or import from cloud storage

Your Resume must be a .doc, .pdf, .docx, .rtf, and no bigger than 1Mb


4000 characters left

All questions are required

Should your application be successful will you require a work permit for the advertised location?

Do you have proven experience working in advance therapy in Phase III?

Do you speak spanish fluently?

Do you speak english fluently?


Marketing Communication

We'd love to send you information about Jobs and Services from Diversity in Research by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on Diversity in Research you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.