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 bioassay specialist who has the knowledge, experience and passion to help provide a world class analytical testing service.
Reporting to the Head of Quality Control, you will be responsible initially for the setting up of the Bioassay Laboratory, procedures and systems. Then on an ongoing basis the management of the testing of Intermediates and Product samples within the Quality Control Laboratory, to include the scheduling of work, supervision of staff and laboratory housekeeping, whilst maintaining compliance with GMP.
The candidate should have demonstrable experience in the 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.
The key responsibilities will include:
• Setting up of bioassay laboratory and the development and qualification of Cell based Potency and ELISA/immunology-based assays for Antibodies and Antibody Drug Conjugates
• Manage the day to day activities of the Bioassay Laboratory, Scheduling, performance and reporting of testing on finished products and stability samples using Cell based Potency assays, cytotoxicity testing and Immunological assays such as ELISA following customer, company and regulatory/industry requirements.
• Maintaining an effective and compliant Laboratory including non-conformance reviews and implementation of corrective actions. Including managing and tracking the progress of deviations within bioassay to ensure that they are closed within the required timelines and to agreed standards.
• Laboratory maintenance- housekeeping, self-inspections and stock control – support the re-order systems and communication with key suppliers to ensure continuous testing capability within budgetary constraints.
• Draft and review laboratory protocols and reports, validation studies and project work.
• Maintain and improve knowledge of bioassays and immunoassays 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.
• Ensure that all of reagents, reference material, analytical techniques and relevant equipment are qualified
• Liaise with maintenance staff and suppliers to ensure laboratory equipment and services are maintained to a high standard and in good working order.
• Ensure training status is compliant with matrix requirements and to assist in training of laboratory and production staff.
• 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 Health & Safety at Work Act 1974.
• Contribute to team building, training and problem-solving initiatives internally and cross site.
• Represent QC on project teams/meetings and client interaction to provide subject matter expert knowledge.
Skills & Qualifications required to undertake this role:
• Degree or equivalent qualification in a relevant Biological subject area.
• At least 4 years’ experience in an analytical testing/bioassay 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.
• Essential knowledge and experience in Cell based bioassays and ELISA testing of biologics/biomolecules.
• 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.
• Be a team member and proven leadership skills.
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**