GMP Cell and Gene Therapy technologist

GMP Cell and Gene Therapy technologist

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 Cell and Gene Therapy Technologist for a new CDMO 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 and gene therapy manufacturing, technology transfer, investigations, and process validation of cell and gene therapies.

Responsibilities:

• Ability to take on and manage multi-disciplined projects, with minimal supervision
• Hands-On manufacturing processing of cell and gene therapy in line with GMP requirements
• Review of completed process documentation
• Ability to train others on the manufacturing equipment and processes
• Revise and create documentation (Standard Operating Procedure (SOP), batch records, reports, notebooks) associated with the manufacture of product, requiring minimal direction
• Incorporate pre-planned process improvements and cost reduction projects into manufacturing
• Complete understanding/application of quality systems
• Support of Health Authority inspections
• Perform area equipment and process validations in accordance with validation procedures requiring minimal direction
• Possesses technical and systems knowledge and is able to research information outside of knowledge base
• Has ability to recognize problems and recommend solutions to problems based on technical understanding of the process and equipment
• Support activities in other departments as instructed by manager e.g. cleaning, material receipt and stock management
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable regulations and industry codes

Experience:

Education and Certifications:

• Bachelor’s degree or equivalent in a science discipline with three (3) or more years of experience or a Masters Degree with Science with 1-2 years relevant experience

Knowledge, Skills, and Abilities:

• Requires functional understanding of Current Good Manufacturing Practices (cGMPs), established manufacturing practices and procedures, and compliance with Quality regulations and guidelines
• Ability to understand and execute established written instructions is essential
• Cell culture and aseptic technique

• Ability to work independently or as part of a team.

Salary Range: Negotiable. Salary is commensurate with experience, qualifications and overall suitability for the position.

Start date: To be confirmed – subject to successful candidate’s notice period.

Location: 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.