Galway, Ireland | Full-time, Permanent role
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 Cell and Gene Therapy Technologist for a new facility in County Galway. This is an exciting role for a highly motivated individual to join a growing organisation and be deeply involved in the start-up and commissioning of the new facility. The candidate will work closely with other internal and external stakeholders to support cell-culture based manufacturing and supply of cell and gene therapies.
- Responsible for supporting production and testing operations in the new cell and gene therapy facility.
- Become proficient on processes within the new facility and train other new hires.
- Creation of SOPs to support the successful start-up and commissioning of the new facility.
- Creation and execution of equipment qualifications and provide support to visiting engineers on site as required.
- Aseptic processing of cells in line with GMP requirements, including filling and cryopreservation.
- Maintain any batch records and production related records as required.
- Creating and maintaining logbooks for equipment.
- If required, supervise student interns and help co-ordinate their work activities.
- Provide support in maintaining the cleanliness and EHS standards of the facility.
- Complete incoming inspections on raw materials and components in line with controlled procedures.
- Review and approval of raw material inspection records.
- Help in collating, trend and presenting Key Performance Indicator (KPI) Data for the facility.
- Test and optimise protocols for production and quality control of viral particles.
- Responsible for authoring protocols, reports, WIs, SOPs and other relevant GMP documents.
- Follow maintenance and cleaning SOPs, keeping work areas clean on a daily basis.
- Order and restock supplies when required. Assist with managing incoming and outgoing materials as well as storage.
- Support regulatory authority inspections and meetings with health authorities if required.
- Minimum MSc in a Cell and Gene Therapy related area.
- Knowledge of cell culture-based manufacturing, technology transfer, investigations, and process validation of cell and gene therapies.
- 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.
- Familiarity of US and European GMPs and Pharmacopeia.
- Excellent written and verbal communication and the ability to multi-task across multiple products and programs is highly important.
- Excellent organizational skills and attention to detail.
- Enthusiastic and self-motivated.
- Able to manage multiple tasks efficiently.
- Competent in using Microsoft Office.
- Familiarity with sterile techniques.
- Attention to detail and application of laboratory safety practices.
- Ability and willingness to adapt to changing priorities and deadlines as well as contribute to other areas of the business.
- Industry experience of working in a GMP manufacturing facility is highly desirable.
- Experience with tissue culture and viral production is advantageous.
- 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, qualifications and overall suitability for the position.
Working hours: Working hours will be 9-5 daily. The nature of the work may require flexibility in working times.
Start date: To be confirmed – subject to successful candidate’s notice period.
Closing date for receipt of applications is 10/10/2021
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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