Microbiologist – Cell and Gene Therapy
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.
Due to rapid growth, HiTech Health are seeking to hire a Microbiologist for a new cell and gene therapy facility in County Galway. This is an exciting role for an aspiring professional to join a growing organisation to work on all microbiological matters within the cell and gene therapy division of HiTech Health. The candidate will work closely with the production team and quality function to support the manufacturing and testing of a range of cell and gene therapy products.
- Authoring microbiological related plans, protocols, reports, SOPs and other relevant GMP documents.
- Oversee the generation of Work Instructions (WIs) and Standard Operating Procedures (SOPs) as pertains to microbiological activities.
- Performing environmental monitoring performance qualifications and routine environmental monitoring programs.
- Performing laboratory-based assays, such as but not limited to growth promotions, gram staining, colony counting, microbial Identification Assays, sterility testing, endotoxin testing etc.
- Subject matter expert and lead in all microbiological related Out of Specification (OOS) or Out of Trend (OOT) analytical results, deviations, investigations, corrective or preventive actions
- Contribute to aseptic process simulations/media fills as required.
- Train others in laboratory procedures where required and execution of analytical testing for microbiology requirements to support any QC, R&D or Manufacturing activity.
- Assist at regulatory authority inspections and meetings with health authorities if required.
- Minimum of Honours Bachelor’s degree in a relevant discipline (Microbiology, Biology, Chemistry or similar).
- A minimum of 3 years Microbiology experience in a GMP facility.
- Thorough knowledge of US and European GMPs and Pharmacopeia.
- Expertise in contamination control of GMP cleanroom facilities.
- Subject matter expert with practical experience of environmental monitoring testing and product testing (e.g. sterility, mycoplasma, endotoxin).
- Attention to detail and application of laboratory safety practices.
- Excellent written and verbal communication and the ability to multi-task across multiple products and programs is highly important.
- 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 qualification in a relevant subject area is desirable.
- Experience in cell culture based manufacturing and molecular techniques, including polymerase chain reaction and sequencing, is highly desirable.
- Experience working in a small-medium company and/or facility start-up.
- Knowledge of emerging technologies, trends, and methodologies.
Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.
Working hours: Working hours will be 9 AM-5.30 PM daily. The nature of the work may require flexibility in working times.
Start date: On completion of recruitment process.
To Apply: Please apply via firstname.lastname@example.org and indicate the position title in the email subject line.
Applications to include a cover letter & CV. References should be made available upon request.
Location: Co. Galway, Ireland
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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