Drug Development Director (CMC)
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.
- 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.
Contact: Neil Dewsbury
Telephone: 0114 238 1728