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QC Microbiologist

Deeside, Flintshire

ADCBio 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 Conjugates (ADCs). Formed in 2010, ADCBio 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 Microbiologist who has the knowledge, experience and passion to help provide a world class analytical testing service.

The candidate should have demonstrable experience in the microbiological testing of pharmaceutical products and environmental monitoring of pharmaceutical facilities/utilities.

The key responsibilities will include:
• Performance and reporting of Analytical testing on intermediates and finished products following customer, company and regulatory/industry requirements (to include: HPLC (SEC, HIC, PLRP) of Proteins/ UV – vis spectrophotometry / pH, conductivity, osmolality / Capillary Electrophoresis, Iso-electric focussing, SDS PAGE / Immuno-assays, ELISA.
• Ensure that analytical results are reported within the most efficient timeframe.
• Working with technical specialists to qualify equipment and Analytical Methods to ICH requirements.
• Performance of routine tasks and other non-routine activities required in support of quality control laboratory functions.
• Laboratory maintenance (housekeeping / self inspections / stock control) and support the re-ordering systems and communication with key suppliers.
• Data trending and assisting in the performance of quality investigations.
• Documentation of laboratory results in accordance with cGMP and company procedures.
• Ensure training status is 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.
• Preparation and execution of laboratory protocols and reports, as assigned.
• Qualification of critical reagents, reference materials and standards.
• 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:
• >2 years’ experience working in an analytical testing laboratory and experience of working in a regulated environment, pharmaceutical, contract testing laboratory or medical laboratory in a related role to cGMP is essential
• Technical knowledge and experience in Protein analysis including techniques such as HPLC, UV, CE, IEF, ELISA, SDS PAGE.
• Understanding 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.
• Be able to work in a team and individually.
• Proficient in the use of computers and using Microsoft Office packages.

ADCBio offer a generous benefits package including a competitive salary ranging between £17,500-£22,500 (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.