Reference Number: JO-2105-468185
Senior Director, Product Development
Job Type: Permanent
Our clients site in Reading and is a growing contract development and manufacturing site (CDMO) consisting of over 80 employees, providing early phase development services through to proof of concept. Of particular focus is the development and GMP manufacture of oral dosage (solids and liquids) and inhaled drug delivery systems.
The Senior Director, Product Development will have line management responsibility for the Development function to define and manage formulation development and technology transfer of investigational medicinal products into manufacturing, to help meet the objectives of the company.
Main tasks and responsibilities:
- To devise and manage the formulation development programme for studies to ensure delivery on time, budget, and quality, including discussions with clients to agree the required extent of development.
- To provide overall leadership of product delivery for studies, with proactive approach to planning and solving issues.
- Responsible for ensuring regular written and verbal updates of the progress of development work are provided, and any issues that may arise, to colleagues and clients.
- To work closely with the project management department from project live to ensure rapid and accurate initiation of study documentation
- To work closely with Business Development in securing new business and projects
- To review and, where appropriate, approve key study documentation to ensure accuracy and consistency.
- To write and approve pharmaceutical development plans, protocols and reports and SOPs where appropriate.
- To provide supervision, management and direction to the Development department and colleagues ensuring operational excellence
- To host client audits on behalf of the development function
- To set and monitor the use of development budgets for studies. Provide input into preparation of annual departmental budgets and pay rises.
- Attendance at study specific meetings and calls as required.
The successful candidate will have a relevant Degree in Science or higher qualification with considerable experience in a development role within the pharmaceutical industry. We are looking for a talented technical leader who thrives in a fast-paced working environment. Excellent interpersonal skills are key for this role as you will lead the Development team, collaborate with other departments and interact with sponsors on a daily basis.
Other skills and experience required:
- Extensive supervisory experience in a Pharmaceutical R&D laboratory
- Knowledge of procedures, processes and systems for a cGMP compliant pharmaceutical development laboratory
- Expertise in product development, validation and troubleshooting
- Extensive knowledge of product development requirements for oral, parenteral and inhaled dosage forms
- Experience in hosting and responding to QA and client audits
- Cross-functional experience and awareness of early Pharmaceutical / Clinical Development
- Understanding of CTA process and experience of compiling IMPD submissions
- Experience in a client-facing role
In return, you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Minimum of 10 years experience advantageous