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A Fantastic opportunity for an experienced Method Development and Validation scientist has become available to join a leading Biopharmaceutical company in the Berkshire area. As the Senior Scientist - Method Development and Validation you will be responsible for providing product purity and impurity method development in support of process and product development and manufacture for antibodies and other recombinant proteins.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Scientist - Method Development and Validation will be varied however the key duties and responsibilities are as follows:
1. Lead a range of Method Development / Transfer and Validation studies for a range of analytical techniques including but not limited to purity, impurity and identity methods e.g. Electrophoresis (Capillary, SDS), IEF (icIEF) and Immunoassays (ELISA).
2. You will troubleshoot and run OOS reports as well as supervise junior members of the team. This includes delivering training; promote good scientific practice and process improvements in line with regulatory requirements.
3. You will work under GMP regulations and will review and approve GMP documentation e.g. SOPs, protocols and reports, regulatory as required.
To be successful in your application to this exciting opportunity as the Senior Scientist - Method Development and Validation we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline e.g. Biochemistry, Biology, Molecular Biology etc. in addition to working in a highly regulated environment e.g. GMP
2. Proven industry experience in a Pharmaceutical or Biopharmaceutical environment with particle experience of Method Development and Validation.
3. Experience of protein analysis and the related techniques (e.g. HPLC, ELISA, iEF, cEF, western blot and SDS-page) will be beneficial to your application.
Key Words: Senior Scientist , Method Development , Validation , Antibodies , Recombinant Proteins , GMP , Purity , SDS-Page , Capillary Electrophoresis , IEF , CE SDS , icIEF , Analytical Development , Analytical Validation , Assay Development
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We 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 recruitment processionals and scientists. We look forward to helping you with your next career moves.