Drug Development Director (CMC)

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  • Niche Pharmaceutical Organisation
  • Central London location
  • Agile, scientifically focussed business
  • Negotiable salary

An exciting opportunity has arisen for a Drug Development Director at a niche pharmaceutical organisation in London.

We are looking for a Drug Development Director to coordinate all formulation, analytical and manufacturing activities, developing a range of products including nasal and injectable technologies.

This represents an excellent opportunity to help develop an agile and pioneering organisation – if this sounds like next stage in your career, please get in touch for a confidential discussion.

Key Roles & Responsibilities:

  • Oversee day to day formulation, analytical, process development and clinical manufacturing activities on a range of projects.
  • Ensure CMC development applies quality by design and risk based product development thinking in accordance with current guidance.
  • Manage CMC developments according to quality standards, SOPs, GxPs and relevant guidelines to fulfil all regulations.
  • Bring product development representation and expertise to project teams.
  • Review and approve protocols, technical data output and status reports for formulation, analytical and manufacturing activities.
  • Conduct quality reviews of CMC development projects to identify best practice and key areas for improvement.
  • Contractor evaluation, selection and management for product development activities.
  • Prepare and review CMC regulatory documents.

Job Requirements:

  • Educated to degree level or equivalent.
  • Minimum of 10 year’s experience in drug product development.
  • Demonstrates ability to execute development processes on quality by design and risk based development guidance.
  • Demonstrates experience in leading the development of drug-device combination products in accordance with US and EU guidance.
  • Excellent interpersonal skills, negotiation skills, and facilitation skills.
  • Demonstrates strong analytical and problem solving skills.
  • Excellent verbal and written communication and computer literacy skills.
  • Ability to work well autonomously and within a multi-disciplinary virtual team environment.