We are currently looking for a Senior/Principal Scientist - Drug Development to join a leading biologics formulation biotechnology company based in the Cambridgeshire area. As the Senior Scientist - Drug Development you will be responsible for the further development and formulation projects focused on biologics.
You will use your knowledge of biologics development and manufacturing to develop and validate a range of assays and techniques. This position would suit an ambitious scientist who has worked in a CMC environment and is aware of ICH stability guidelines and regulations. This is a great opportunity for someone to step into a project and people leadership role.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior/Principal Scientist - Drug Development will be varied however the key duties and responsibilities are as follows:
1. Lead, design, develop and manage your own studies where you will also have line management responsibility of junior members of the team (2 - 3 people)
2. You will act as project manager to ensure the smooth running and success of projects. You will have the opportunity to work cross-functionally within a small business where you will have the opportunity to make an impact at all levels.
3. Ensure the stable formulation of a range of drug products and ensure the successful transfer into a CMC, regulated environment.
4. Use your knowledge and experience of Protein Characterisation techniques including but not limited to HPLC, RP-HPLC, SEC, CEX, CE-SDS and DLS to ensure the stability of protein drug products.
To be successful in your application to this exciting opportunity as the Senior/Principal Scientist - Drug Development we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences discipline, ideally a PhD focused on Protein Development / Characterisation / Formulation.
2. Proven industry experience in Biopharmaceutical / Pharmaceutical where you have worked in a Protein Chemistry or Biochemistry team. Ideally you will have experience of Protein CMC and Stability including Quality and Regulatory guidelines such as GLP / GMP / ICH etc.
3. A working knowledge and practical experience with Characterisation such as SEC, HPLC, CEX, CE-SDS or DLS. Formulation experience would be advantageous.
Key Words: Characterisation | Formulation | Biochemistry | Pharmaceutical Product Development | Stability | GMP | CMC | SEC | HPLC | CEX | CE-SDS | Biologics | Cambridge