Role:- Biochemistry Team Leader- QC (Pharma/biotech)
Reporting to: - Head of QC
Salary: - Competitive
Russell-Taylor Group have a fantastic opportunity for an individual with at least 4 years' experience in a testing laboratory to GMP standards to join a rapidly growing Biotechnology drug discovery company. The role has come about due to growth in the company- if you have team management experience, experience of various analytical techniques and have a good understanding of GMP regulations please apply within.
- Responsible for the management of Biochemistry testing of intermediates and product samples in the QC lab.
- Organise the scheduling of work and supervision & management of staff and laboratory housekeeping whilst maintaining compliance to GMP
- Development & Validation of assays for the analytics of Therapeutic Proteins or Monoclonal antibodies following customer, client and regulatory requirements.
- Maintain an effective and compliant process in support of manufacturing operations, (non-conformance reviews and implementation of corrective actions).
- Initiate, manage and track the progress of deviations 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 and within budget.
- Draft and review laboratory protocols and reports, validation studies and project work.
- Maintain and improve knowledge of analytical techniques.
- Contribute to providing new and improved methods of working or equipment and to provide trouble shooting and problem solving.
- Liaise with maintenance staff and suppliers to ensure laboratory equipment and services are maintained to an excellent standard
- 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 reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974.
- Represent QC on project teams/meetings and client interaction
- BSC or equivalent qualification in a Scientific subject, (chemical or biological would be preferred)
- A minimum of 4 years' experience in an analytical testing laboratory (essential)
- Experience of working in a pharmaceutical environment to GMP (essential)
- Proven management and leadership skills (essential)
- Working knowledge and expertise in the techniques of HPLC, UV, of Proteins/Antibodies including development and validation of methods (essential)
- Working knowledge and expertise in the techniques of, CE/CESDS, cIEF & ELISA (desirable)
- Good understanding and application regulatory requirements including PhEur, USP, Orange guide and Current ICH guideline (desirable)
- Excellent communication / interpersonal and organisational skills,