J5305CheshirePharmaceutical CRO/CMO PermanentDependent on ExperienceFull Time15/03/2018Biochemistry Biochemistry – QC / Stability Bioanalytical Immunoassay Quality Assurance Production - Quality Control Management Quality Assurance - Biologics
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A fantastic opportunity for a Senior QC Analytical Scientist to join a leading Biologics company based in the North West in order to set up a brand new analytical laboratory, has become available. As the Senior QC Analytical Scientist you will be responsible for the initial development of the analytical testing facility as well as the timely and compliant analytical testing service to support manufacturing operations of Biologics. This includes all raw materials, intermediates and finished products following customer, company and regulatory/industry requirements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior QC Analytical Scientist will be varied however the key duties and responsibilities are as follows:
1. You will use your knowledge of raw material sampling, Pharmacopoeial testing (BP,EP,USP) and finished product testing of biologics / biomolecules to coordinate, support training and lead the sampling and testing to ensure sampling operations are performed and reported in accordance to regulatory/industry standards.
2. You will initiate, manage and track the progress of deviations and Maintain all stock of media and consumables to ensure continuous testing capability within budgetary constraints
3. Manage the day-to-day activities of the laboratory as well as draft and review laboratory protocols and reports, validation studies and project work ensuring all records and work undertaken are kept in accord with cGMP and company procedures.
4. 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.
To be successful in your application to this exciting opportunity as the Senior QC Analytical Scientist we are looking to identify the following on your profile and past history:
1. A degree in a relevant Chemical or Biological subject (e.g. Biology, Chemistry, Biochemistry, Pharmaceutical Sciences etc.)
2. Proven industry experience in a Pharmaceutical / Biopharmaceutical analytical testing environment with knowledge of HPLC, UV, FTIR, Titration, TOC. Experience with KF, CE, IEF, ELISA, SDS PAGE and Cell based bioassays is desirable.
3. A working knowledge and practical experience with of cGMP and regulatory requirements including USP, PhEur, Orange guide and Current ICH guidelines.
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.