We are currently looking for a Formulation Development Specialist within Lyophilisation to join a leading Pharmaceutical company based in the North Wales area. As the Formulation Development Specialist you will be responsible for the routine formulation development of methods and technologies for on line measurement of key process attributes, with a focus on Lyophilisation. You will execute work plans and provide technical updates to project teams in addition to supporting regulatory strategy and provide input into non clinical and clinical sections with respects to drug product formulation and presentation.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Formulation Development Specialist within Lyophilisation will be varied however the key duties and responsibilities are as follows:
1. Providing clear plans for developing robust parameters for optimisation of Lyophilisation cycle while identifying and implementing state of the art technologies to allow for on line or at line measurements of process parameters to accelerate development of manufacturing and Lyophilisation processes.
2. Design and execute accelerated stability testing plans that demonstrate suitability of Lyophilised formulations to support effective novel biologic non-clinical and clinical dosing requirements.
3. Provide technical input for Biologics Development projects, supporting Project Management and Global Project Teams to provide effective partnerships with Clinical, Regulatory, Commercial, and Business Development as part of an integrated Biologics development team.
4. Maintain up to date knowledge on protein formulation techniques issues and development strategies as well as actively assessing emerging techniques in the field either internally or via external collaboration.
To be successful in your application to this exciting opportunity as the Formulation Development Specialist in Lyophilisation we are looking to identify the following on your profile and past history:
1. Relevant degree in a Biological or Chemical discipline, ideally followed by a PhD with a focus on Formulation Development.
2. Proven industry experience in Biologic Formulation Development.
3. A working knowledge and practical experience with the development of Lyophilisation processes, scale up and transfer to a GMP facility.
Key Words: Biologics | Formulation Development | Lyophilisation | Scale up | Transfer | GMP | HPLC | CD | UV | CE | FTIR | Protein Degradation | Protein Aggregation | Protein Fragmentation | Stability testing
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Posted: 11th July 2017
- Expires: 8th August 2017
- Reference: J3772