CGT Technologist

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.

Responsibilities:

  • 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.

Essential Requirements:

  • 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.

Desirable Requirements:

  • 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.

To Apply:

Applications to include a cover letter, CV, and the contact details of two referees should be sent, via e-mail (in word or PDF only) to  recruitment@hrduo.com  and info@hitech-health.com

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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