BACK TO CAREERS PAGE

QC ANALYTICAL SCIENTIST

Deeside, Flintshire, CH5 2AU

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 and experience to help provide a world class analytical testing service.

 

Reporting to the QC Senior Analytical Scientist, you will be responsible for the performance of analytical testing to support manufacturing operations and other customers.

The candidate must have a demonstrable experience in the analytical testing of Biological Pharmaceutical products, Therapeutic Proteins or Monoclonal antibodies and possess the technical knowledge to support the development and qualification of suitable compliant assays in a regulated environment.

The key responsibilities will include:.

  • Performance and reporting of analytical testing on all raw materials, intermediates and finished products following customer, company and regulatory/industry requirements.
  • Including :-Pharmacopoeial testing; HPLC (SEC, HIC, PLRP); Capillary Electrophoresis; Iso-electric focusing; SDS PAGE; Immuno-assays; ELISA; Cell based bioassays; UV – vis spectrophotometry; FTIR; Titration; TOC and Karl Fisher.
  • 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
  • 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
  • Preparation and execution of laboratory protocols and reports, as assigned.
  • Qualification of reagents, reference material, analytical techniques and relevant equipment.
  • 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:

  • HND or equivalent qualification in a relevant Chemistry/ Biological subject area.
  • At least 2 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 techniques such as HPLC of Proteins/Antibodies, CE, IEF, ELISA, SDS PAGE, Cell based bioassays is essential.
  • Technical experience in techniques such as UV, FTIR, KF, TOC, Titration is desirable.
  • 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.
  • Degree or equivalent qualification in a relevant chemical or biological subject area.In the first instance, please attach your CV and current remuneration details/expectations.

 

We award our teams with a highly competitive remuneration package which will be discussed at interview stage.   Please apply with a covering letter detailing your current remuneration package.

Apply Now.