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 Analyst who has the knowledge, experience and passion to help provide a world class analytical testing service.
Reporting to the QC Team Leader, you will be responsible for the performance of laboratory operations, to include the testing, in-process and product release samples using analytical methods.
The candidate must have a demonstrable experience in the use of a variety of analytical methods, A self-motivational attitude and the ability and aptitude to learn new skills within a fast-paced environment.
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 none routine activities required in support of quality control laboratory functions.
• Laboratory maintenance- housekeeping, self-inspections and stock control – 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 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 p.a. (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 CV with a covering letter detailing your current remuneration package.
**NO CALLS FROM AGENCIES WILL BE TAKEN IN RELATION TO THIS VACANCY**