Drug Development Director (CMC)
This Listing has Expired
We are sorry to say that this job is no longer available. However we are experts in recruitment and we are sure we can help you. You can view the related jobs on this page and if there is nothing suitable then please contact us on 0114 238 0012, register your CV, or register for job alerts all in confidence.
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.