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QC Analytical Scientist

Deeside, Flintshire

ADC BIO is an innovative biotechnology company developing new process technology to speed, simplify and significantly lower the production costs of the latest generation of anti-cancer blockbuster drugs, Antibody Drug Conjugated (ADCs). Formed in 2010, ADC BIO have recently secured significant investment that is enabling a new dedicated 6500m2 facility in Deeside to support the rapid expansion plans of the Company.

To support this growth, we are recruiting a QC Analytical Scientist who has the knowledge, experience and passion to help provide a world class analytical testing service. The candidate should have demonstrable experience in the analytical testing of Biological Pharmaceutical products such as Therapeutic Proteins or Monoclonal antibodies and possess the technical knowledge to support the development and qualification of suitable compliant assays in a regulated environment.

Reporting to the Biochemistry Team Leader, you will be responsible for: 

  • Taking 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.
  • Ensure 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
  • Ensure 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.

 

Skills & Qualifications required to undertake this role:

  • 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.

 

ADCBio offer a generous benefits package including a competitive salary (negotiable depending on experience and qualifications) plus 25 days holiday + statutory (+ death in service and private medical cover following a qualifying period).

Please apply by emailing a copy of your CV along with a covering letter detailing your current remuneration package.

**NO CALLS FROM AGENCIES WILL BE TAKEN IN RELATION TO THIS VACANCY**

 

Apply Now.