QC Analytical Scientist

Russell Taylor Group Ltd ,
Chester, Cheshire
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Overview

Role: QC Analytical Scientist Location: Chester Salary: DOE Russell Taylor Group have a fantastic opportunity for an experienced analyst, who has worked within the pharmaceutical or medical industry, to join an expanding biotechnology company who specialise within oncological drug development. Role: Take the lead role in the development and validation of Capillary electrophoresis-based assays for Antibodies and Antibody Drug Conjugates Performance and reporting of analytical testing on, intermediates, finished products and stability samples in capillary electrophoretic methods Preparation and execution of laboratory protocols and reports, as assigned. Qualification of reagents and reference materials, Acting as Subject matter expert at cross- functional project meetings In addition, following the completion of training and qualification, the performance of Analytical testing using a variety of techniques including: HPLC (SEC, HIC, PLRP etc); ELISA; spectrophotometry; FTIR and UV - vis; MS Performance of routine tasks and other none routine activities required in support of quality control laboratory functions. Ensuring all testing performed is reported within the most efficient timeframe. Laboratory maintenance- housekeeping, self-inspections and stock control - support the re-order systems and communication with key suppliers. Data trending and performance of quality investigations Documentation of laboratory results in accordance with cGMP and company procedures. Ensure training status compliant with matrix requirements and to assist in training of laboratory and production staff. Maintain and improve knowledge of analytical techniques and procedures Contribute to team building, training and problem-solving initiatives internally and cross site. Liaise with functional groups both within and outside QC as appropriate to ensure projects and plans are progressed Ensuring that all laboratory activities are in compliance with all Health & Safety Guidelines, with particular reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974. Person: BSc or equivalent qualification in a relevant Chemistry/ Biological subject area. At least 4 years' experience in an analytical testing laboratory and experience of working in a regulated environment, pharmaceutical or medical laboratory in a related role to cGMP or within alternative quality system (UKAS/ISO 9001) such as Contract testing laboratory. Technical experience in Capillary Electrophoresis analysis of Biomolecules is essential. Technical experience in techniques such as HPLC, Cell culture, Immunoassays, UV,MS is an advantage. Good understanding and application of cGMP and regulatory requirements including USP, PhEur, Orange guide and Current ICH guidelines applicable to the role. Excellent communication / interpersonal and organisational skills, demonstrating attention to detail and be able to work in a team and individually. Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r r u s s e l l - t a y l o r . c o . u k

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