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An exciting opportunity for an experienced Biologics QC Scientist has become available to join a leading Biopharmaceutical company based in Hertfordshire as their Quality Control Lead. As the Quality Control Lead you will be responsible for the management of QC analytical strategies, selection and management of external contracted partner as well as the developing their internal QC capabilities.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Control Lead will be varied however the key duties and responsibilities are as follows:
1. Support and manage identified / allocated outsourced programmes of work, providing scientific scrutiny and interpretation, ensuring compliant testing outcomes as well as the management of analytical methods transfer, development and validation at and between partner contract research organisations.
2. Develop in house QC capabilities including Raw Material testing, Safety Testing, Environmental Monitoring and Analytical testing of Gene Therapy products.
3. Set-up the QC laboratory to regulatory standards. This includes writing SOPs, dealing with regulatory agencies (MHRA), managing QMS systems, writing Quality documentation and acquiring laboratory equipment and completing subsequent validation.
4. You will build a leading GMP QC testing laboratory and collaborate with the senior CMC scientific team and Quality Assurance to ensure successful product delivery.
To be successful in your application to this exciting opportunity as the Quality Control Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences discipline in addition to experience of Quality Control testing of Biotechnology / Biopharmaceutical / Vaccine products gained within an industrial field.
2. Proven industry experience and awareness of GMP QC testing regulations in addition to regulatory compliance with the MHRA. The ability to demonstrate knowledge of the documentation requirements for GMP Quality Control including maintenance of data integrity, computer systems validation, equipment procurement and qualification will be beneficial.
3. A working knowledge and practical experience with Physicochemical, Biochemical, and Biological assays (e.g. ELISA, PCR, Cell based Assays, HPLC, Stability Testing, EM etc.) is essential as well as working within controlled document systems, the faithful reporting of data, generation of certificates, protocols, SOPs and written reports.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.