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 our product development laboratory located in Co. Galway. The candidate will undertake and help coordinate R&D manufacturing and QC activities leading to the development and manufacture of novel therapeutics in the gene and cell therapy space. This is an exciting role for a highly motivated individual to join our rapidly growing organisation. We are seeking a dynamic and hardworking individual who is interested in helping to develop the next generation of therapeutics.

Responsibilities:

• To play a key role in the development and translation of cell and gene therapy products e.g. process development, technology transfer, GMP translation, QC assay development.
• To ensure efficient transfer of development processes and assays to GMP validation by working closely with members of product development, quality and cGMP teams across HiTech Health and where appropriate with external clients.
• Ability to take on and manage multi-disciplined projects, with minimal supervision.
• Test and perform analytical, safety and potency assays of products including but not limited to: flow cytometry, cell culture, PCR, and ELISA assays.
• Revise and create documentation (Standard Operating Procedure (SOP), batch records, reports, etc.) associated with the manufacture of products, requiring minimal direction.
• Support process changes and work to meet the clients’ requirements.
• Work with the wider team to support R&D activities.
• 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.

Essential Requirements:

Honours 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.

• Hands-on technical experience in all or some of the following; cell culture, flow cytometry, molecular biology techniques.
• Excellent written and verbal communication and the ability to multi-task across multiple products and programs is critical.
• Enthusiastic and self-motivated.
• Able to manage multiple tasks efficiently.
• Ability to work independently or as part of a team.

Desirable Requirements:

• Knowledge of cell culture-based manufacturing, technology transfer, and process validation of cell and gene therapies.
• MSc in a relevant subject area is 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 jobs@hitech-health.com and indicate the position title in the email subject line.

Location: Spiddal, 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.

Ireland | Permanent full-time role & flexible working conditions

The role of QP involves supporting the management of HTH’s Quality Management System to ensure it is efficient, effective and compliant at all times. The role also involves supporting Quality Assurance activities for HTH and for its clients. The QP will be responsible for ensuring compliance with U.S. and/or E.U. regulatory requirements for manufacturing and release and for clinical supply to patients.

Responsibilities:

• Fulfilling the role of the Qualified Person within the company in accordance with EU Directives 2001/83/EC, and relevant current guidelines for commercially available product and/or clinical trial material.
• Act as day-to-day Quality lead within the CDMO facility, ensuring compliance to GMP and company procedures
• Working closely with clients to ensure that products manufactured by contract organisations meet compliance with all relevant regulatory requirements and the client’s internal quality standards.
• Performing batch documentation review and batch certification
• Coordinating and performing any required internal/client investigations and the issuance of follow up reports (e.g. rejected batches, deviations, CAPAs, OOS).
• Ability to generate GxP documentation which is of a high standard. QA review of documentation, including SOPs, Protocols, Batch Records, Validation documents and Quality Technical Agreements (QTAs) to ensure GMP compliance.
• Acting as a point of primary contact for clients.
• Advising and providing input to company and clients’ quality management systems.
• Conducting GMP and GDP audits internally and on behalf of clients and subsequent issuance of reports.
• Participating in cross-functional projects for the development and scale-up of products.
• Reporting directly to the Head of Quality & Compliance on a regular basis to ensure company and client goals are being met in line with quality and compliance standards.
• Creating and delivering GMP training internally or externally on behalf of clients
• Responsible for the day-to-day support of HTH QMS to ensure it is operating efficiently, effectively and in a compliant manner
• Facilitating and/or supporting regulatory inspections and customer audits 

Requirements:

• Third level Degree in Science or relevant discipline.
• QP Qualification is essential.
• Minimum 5 years of experience in Pharmaceutical industry in a Quality role.
• Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
• Auditing experience of suppliers in pharmaceutical industry.
• Biotechnology compliance knowledge and experience.
• Experience in at least one of the following areas is preferred: aseptic processing/sterile manufacturing, biologics manufacturing, cell and gene therapy manufacturing
• Experience in participation in/leading regulatory and customer audits
• Experience in people management.
• Ability to critically assess situations and make strategic decisions.
• Excellent written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Ability to handle and prioritise multiple assignments, changing priorities and meet deadlines. Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Travel expected approx 10-20% of time to support clients.

Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.

Working hours: Working hours will be 9-5.30 daily. The nature of the work may require flexibility in working times. Hitech Health provides flexible working options for employees.

Start date: On completion of recruitment process.

To Apply: Please send your application to joneill@hitech-health.com.

We reserve the right to re-advertise or extend the closing date for this job post.

HiTech Health is an equal opportunities employer.