On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and...
QC Specialist – Cell and Gene Therapy
Galway, Ireland | Permanent full-time role & flexible working conditions
HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. The company was established in 2013, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports cell and gene therapy companies develop, manufacture and supply life-changing therapies to patients.
HiTech Health are seeking to hire a QC specialist for a new cell and gene therapy facility in County Galway. This is an exciting role for a highly motivated individual to join a growing organisation and be deeply involved in quality control testing of starting material, in-process samples and also final product release testing. The QC specialist will play an integral part of the release of clinical/commercial ATMP products.
- Test and perform analytical, safety and potency assays for Cell and Gene Therapy products including but not limited to; flow cytometry, cell culture, PCR, DNA gels, western blots and ELISA assays.
- Perform in-process and final product inspections.
- Responsible for authoring QC related Work Instructions, SOPs, client specific validation protocols & validation reports, and other relevant GMP documents.
- Subject matter expert for completion of Out of Specification (OOS) or Out of Trend (OOT) analytical results, deviations, investigations, corrective or preventive actions.
- Complete incoming inspections on raw materials and components in line with controlled procedures and approve raw material inspection records.
- Perform laboratory functions such as daily equipment QC maintenance, inventory management, accessioning samples, data entry, and providing routine administrative support.
- Support process changes from a QC perspective.
- Maintain cleanliness of laboratory preparation areas and equipment.
- Participate in and support HTH equipment qualification programme for QC equipment.
- Prepare, package and label test samples or products for shipping to test sites and other destinations.
- Participate at regulatory authority and customer inspections and meetings as QC representative.
- BSc in Life Sciences.
- Minimum of 3 years technical experience.
- Demonstrative technical experience in flow cytometry, cell culture and PCR assays is essential.
- Knowledge of cell culture-based manufacturing, technology transfer, investigations, and process validation of cell and gene therapies.
- Excellent written and verbal communication and the ability to multi-task across multiple products and programs is highly important.
- Enthusiastic and self-motivated.
- Able to manage multiple tasks efficiently.
- Proficient in technical writing and experience in creating; SOPs, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
- MSc in a relevant subject area is desirable.
- Experience working with ATMPs.
- Experience in a GMP laboratory.
Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.
Working hours: Working hours will be 37.5 hrs pw
Start date: To be confirmed – subject to successful candidate’s notice period.
Closing date for receipt of applications is 11th February 2022
We reserve the right to re-advertise or extend the closing date for this job post.
HiTech Health is an equal opportunities employer.
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