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QC Analytical Scientist

Vacancy Title: QC Analytical Scientist
Contract Type: Permanent
Location: North West England, England
Industry:
Salary: Negotiable
REF: J905454_1589888625
Contact Name: Hannah Williams
Contact Email: Hannah.Williams@russell-taylor.co.uk
Vacancy Published: 6 days ago

Vacancy Description

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.

Key Words: Biotechnology, Capillary electrophoresis-based assays, HPLC, cGMP, Immunoassays, ELISA, Validation, Development, Antibodies.

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