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 Senior QC Analytical Scientists who will be responsible for the provision of a timely and compliant analytical testing service to support Manufacturing operations and other customers.
Reporting to the Quality Control Manager the key responsibilities will include:
- Ensure that analytical testing is performed and reported on all raw materials, intermediates and finished products following customer, company and regulatory/industry requirements.
- Coordinate, support training and lead the sampling and testing of raw materials to ensure sampling operations are performed and reported in accordance to regulatory/industry standards.
- Perform and supervise the testing on samples to guarantee that they are reported within the most efficient timeframe.
- Initiate, manage and track the progress of deviations within own area to ensure that they are closed within the required timelines and to agreed standards.
- Maintain all stock of media and consumables to ensure continuous testing capability within budgetary constraints.
- Manage the day to day activities of the laboratory, ensuring a timely, effective and compliant operation in support of manufacturing operations, including non-conformance reviews and implementation of corrective actions.
- Draft and review laboratory protocols and reports, validation studies and project work.
- Maintain and improve knowledge of analytical techniques and contribute to providing new and improved methods of working or equipment and to provide trouble shooting and problem solving to resolve issues in a timely manner.
- Liaise with maintenance staff and suppliers to ensure laboratory equipment and services are maintained to a high standard and in good working order.
- Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
- Assist QA in the performance of internal and external audits as required.
- Ensure the compliance of all laboratory procedures and personnel with all Health & Safety Guidelines, with particular reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974.
- Contribute to team building, training and problem-solving initiatives internally and cross site
- Represent QC on project teams and in meetings to provide subject matter expert analytical/ bioassay knowledge.
Skills & Qualifications required to undertake this role:
- Degree or equivalent qualification in a relevant chemical or biological subject area.
- At least 4 years’ experience in an analytical testing laboratory and experience of working in a pharmaceutical controlled environment is essential.
- Essential knowledge in the areas of Raw material sampling, Pharmacopoeial testing (BP,EP,USP), finished product testing of biologics/biomolecules.
- Essential working knowledge and expertise in the techniques of HPLC, UV, FTIR, Titration, TOC.
- Desirable working knowledge and expertise in the techniques of KF, CE, IEF, ELISA, SDS PAGE, Cell based bioassays.
- 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 skills.
- Excellent organisational skills.
- Attention to detail.
- Be a team member and demonstrate leadership skills.
We award our teams with a highly competitive remuneration package which will be discussed at interview stage.
In the first instance, please attach your CV and current remuneration details/expectations.