Job Reference: J5635049
Updated On: 13/09/2021
Status: Open to Applications
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Role OverviewWe are currently looking for a QC Analytics Principal Specialist - Gene Therapy to join a leading Gene Therapy company based in the London area. As the QC Analytics Principal Specialist you will be responsible for leading and providing scientific and technical support to analytical method transfer within the company network and to 3rd party laboratories.
Key Duties and ResponsibilitiesYour duties as the QC Analytics Principal Specialist - Gene Therapy will be varied however the key duties and responsibilities are as follows:
1. As the QC Analytics Principal Specialist you will represent the company as the QC Gene Therapy expert in analytical matters with the company's partners and during regulatory inspections and audits.
2. You will ensure analytical methods are fit for purpose in compliance with applicable regulations and company QMS.
3. The QC Analytics Principal Specialist will be responsible for keeping up to date with latest developments in methods and regulation for ATMP analytics through networks and conferences.
4. You will also review and approve GMP documentation e.g. deviation and any change proposals related to analytical issues whilst ensuring that all work complies with GMP.
Role RequirementsTo be successful in your application to this exciting opportunity as the QC Analytics Principal Specialist - Gene Therapy we are looking to identify the following on your profile and past history:
1. Relevant MSc or PhD in a Life Sciences related discipline plus significant industry experience.
2. Proven industry experience working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site.
3. A working knowledge and practical experience using QC analytical technologies and methods within Gene Therapy.
Key Words: Gene Therapy / QC / Quality Control / Analytics / Analytical / Pharmaceutical / Biopharmaceutical / Life Sciences / Sterile / Manufacturing / Aseptic / Biotech / GMP / Good Manufacturing Practice / ELISA / PCR.
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