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 Team Leader 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 for the management of the Biochemistry 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 analytical testing of Biological Pharmaceutical products such as Therapeutic Proteins or Monoclonal antibodies and possess the technical knowledge to support the implementation and qualification of suitable compliant assays in a regulated environment.
The key responsibilities will include:
• Managing the day to day activities of the Analytical QC laboratory, scheduling of testing and ensuring reported within the most efficient timeframe.
• Maintaining an effective and compliant operation in support of manufacturing operations, including non-conformance reviews and implementation of corrective actions.
• Management and supervision of QC Personnel and performance assessments
• Coordinate, support training and lead the analytical testing on all intermediates and finished products, ensuring it is performed and reported following customer, company and regulatory/industry requirements.
• 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 reagents and consumables 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 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/meetings and client interaction to provide subject matter expert knowledge.
Skills & Qualifications:
• 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 to GMP is essential.
• •Essential working knowledge and expertise in the techniques of HPLC, UV, of Proteins.
• Desirable working knowledge and expertise in the techniques o, CE, IEF, ELISA, SDS PAGE
• 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 management and 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**