Senior Project Scientist

Role Overview

Due to business expansion and growth, we are looking for a Senior Project Scientist to join a the Development Team of a global pharmaceutical company based in the Berkshire area. As the Senior Project Scientist you will be acting as the CMC leader, working closely alongside our Project Management team supporting all project set-up activities within Pharmaceutical Sciences and you will interact with clients from the initiation of the programme.

This is a client-facing role. You will be working with a multifunctional team, therefore you will be required to work and communicate effectively across different areas of the business. Being able to build strong working relationships and to collaborate with colleagues and clients is key to being successful in this position.

Key Duties and Responsibilities

Your duties as the Senior Project Scientist will be varied however the key duties and responsibilities are as follows:

1. Leading the product development team, and technical expert oversight throughout project lifecycle. Communication of technical progress to clients.

2. Ensuring the timely completion of development plans and reports, analytical qualification protocol, reports and laboratory write-ups.

3. Formulation development aspects of the development programmes and the ensuring the provision of draft batch records to manufacturing operations.

4. Ensuring smooth transition of programmes to GMP Operations including the provision of batch records and draft IMP labels.

5. Supporting the project set-up activities within Pharmaceutical Sciences. Writing of analytical and formulation test protocols and reports.

6. Identification of excipients and preparation of relevant specifications relating to study requirements

7. Training of new/existing staff. Writing and updating SOPs and analytical methods.

8. Investigation / review / and completion of deviations and CAPAs where appropriate

Role Requirements

To be successful in your application to this exciting opportunity as the Senior Project Scientist we are looking to identify the following on your profile and past history:

1. Relevant degree in a pharmaceutical related subject (eg, pharmacy, pharmaceutical science, formulation science) plus pharmaceutical industry experience. You will also demonstrate CMC or study lead experience.

2. Excellent project management, teamwork and communication skills are essential in this role.