To support this growth, we are recruiting a Senior QC Analytical Scientist who has the knowledge, experience and passion to help provide a world class analytical testing service.
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 development and qualification of suitable compliant assays in a regulated environment.
Reporting to the Head of QC, you will be responsible for
- 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.
- Management and supervision of QC Personnel with scheduling of work packages
- 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.
- 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:
- 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 and organisational skills, demonstrating attention to detail.
- Be a team member and proven management and leadership skills.
Salary & Benefits Package
Salary will be commensurate with experience and is likely to be in the range of £30,000 to £40,000 per annum base on a 40 hour week.
Other benefits include a generous holiday entitlement of 25 days plus 8 bank holidays.
Plus a 3% contribution to a workplace pension (Peoples pension) and private medical healthcare & death in service benefit (following the probationary/qualifying period).