Senior Development Scientist

4 weeks ago

London Area, United Kingdom Hyper Recruitment Solutions Full time

We are currently looking for a Senior Analytical Development Scientist to join a leading developing Gene Therapy company based in London. As the Senior Analytical Development Scientist you will be responsible for the driving the development of analytical assays for AAV product and process characterisation.


This opportunity would suit a Scientist with subject matter expertise in HPLC and other chromatography based analytical techniques, who also has experience analysing protein based products to support the hiring company's transition from pre-clinical and early stage to trials and commercial launch of products.


KEY DUTIES AND RESPONSIBILITIES:


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


1. You will Develop and deliver HPLC based methods for AAV product and process characterisation. Methods of interest include but are not limited to, HPCE, cIEF, CE-SDS, MS and LCMS for large molecule characterisation.


2. You will manage projects, supporting and up-skilling Analytical Scientists within the team, and apply industry knowledge to scope new technologies applicable for AAV product and process characterisation.


3. You will Tech Transfer to external manufacturing partners, work closely with the CMC team and support process analytical activities to support process development, as well as R&D teams focused on new technology development.


4. You will support the regulatory team in providing SME analytical guidance, design and write experimental plans, and ensure data is handled accordingly to strict guidelines.


ROLE REQUIREMENTS:


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


1. Relevant degree in a Biochemistry, Biochemical Engineering degree or relevant. A PhD is not required but advantageous.


2. Proven industry experience where you have used Chromatography based techniques as an analytical tool for the assessment of Large Molecules. Experience of method development and troubleshooting analytical assays is highly beneficial to this role.


3. A working knowledge and practical experience working with AAV gene therapy within a GMP analytical testing environment.


Key Words: Analytical Development | Method Development | Assay Development | MDV | Protein Characterisation | Product Characterisation | Protein Analysis | AAV | Viral Vector | Gene Therapy | GMP | QC | Quality Control | CMC | Biologics | Biopharmaceutical | C&GT | ATMP

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