PMTC Spotlight – HiTech Health

PMTC Spotlight – HiTech Health

HiTech Health is delighted to be selected as the ‘Spotlight’ company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight.

 

HiTech Health is a full-service Contract Development and Manufacturing Organisation (CDMO) in the cell and gene therapy space. We have added GMP Clean Rooms to our state-of-the-art laboratories in Galway, allowing for the manufacture of clinical materials. This adds significantly to existing capabilities which includes process, analytical development and supporting services.

 

Please email info@hitech-health.com to request further information on the range of services HiTech Health can provide.

Cell and Gene Therapy Technologist

Cell and Gene Therapy Technologist

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, qualifications and overall suitability for the position.

Working hours: Working hours will be 37.5 hours

Start date: On competition of recruitment process

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.

Recent News

PMTC Spotlight – HiTech Health

HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight.   HiTech Health is a full-service Contract Development and Manufacturing...

Stay Up To Date

Connect with us to receive the latest HiTech Health and industry updates.

GMP Cell and Gene Therapy technologist

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.

 

Recent News

PMTC Spotlight – HiTech Health

HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight.   HiTech Health is a full-service Contract Development and Manufacturing...

Stay Up To Date

Connect with us to receive the latest HiTech Health and industry updates.

Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance

Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance

Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the product delivered maintains its quality and integrity and remains within the legal supply chain during storage and transportation. This means that the legal owner of the product must have full oversight and traceability of the product at all times during distribution, ensuring that falsified and counterfeit medicines do not enter the product supply network. Below are three key points to consider when seeking to comply with Good Distribution Practice (GDP).

 

  1. Are GDP Self-Inspections being performed?

Performing self-inspections to ensure your company is maintaining compliance with the latest GDP requirements can be beneficial. Self-inspections can support identifying gaps and areas that are higher risk in your supply chain. An internal team assigned with the task of performing GDP self-inspections can:

  • Critically review processes and procedures to check that the company is conducting supply chain activities in a GDP-compliant manner
  • Review CAPAs and ensure that they are implemented and closed
  • Examine records and agreements as well as procedures to ensure there are no deficiencies

Regular self-inspections can help foster a company culture of continuous improvement and compliance.

 

  1. Does your company perform Bona Fide Checks on Customers and Suppliers?

Bona fide checks, in simple terms, provide evidence that someone is who they say they are, or has the authority and experience they claim to have. Performing bona fide checks is an activity that can often be overlooked in the pharmaceutical industry but is essential for maintaining GDP compliance. Regulatory deficiencies may include:

  • No bona fide checks carried out at all
  • No verification that customers or suppliers are authorised to perform the operations that they are performing
  • The address of the customer or supplier has not been verified, or the wrong address is provided
  • Licences of the customers or suppliers not requested and reviewed. For example, a wholesaling partner who does not provide a copy of a Wholesale Distribution Authorisation (WDA) licence in the EU

Ensuring your company has a well defined procedure for performing bona fide checks and appropriately qualifying customers and suppliers can help ensure GDP compliance.

 

  1. Are company employees being effectively trained on GDP?

Personnel involved in the supply chain activities of medicinal products are required to receive training on GDP and how it pertains to the duties they perform. Deficiencies that may be observed during a regulatory audit include:

  • Personnel conducting duties prior to being trained on the relevant procedures, guidelines, and legislation of GDP
  • When a Responsible Person (RP) has been assigned, a role profile (job description) did not include all the required responsibilities as per Chapter 2 of the EU guidelines
  • No evidence of maintaining competence through regular training/refresher training
  • There was no company requirement for an assessment of the effectiveness of training to be conducted or it was not conducted adequately

Developing a training programme that is based around the guidelines and legislation will support safeguarding end users against potential hazards in the supply chain.

 

Contact us today for further information on ensuring GDP compliance. HiTech Health have a team of Qualified Persons (QPs) and Responsible Persons (RPs) available to support your product portfolio.

 

Find us on LinkedIn

Email: info@hitech-health.com

 

References:

EudraLex Directive 2013/C 343/01 Guidelines on Good Distribution Practice of Medicinal Products for Human Use

Health Products Regulatory Authority (HPRA) – Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances

HPRA GDP Information Day – May 2022 – http://www.hpra.ie/homepage/medicines/news-events/item?t=/gdp-and-gmp-conferences-registration-announcement&id=50581126-9782-6eee-9b55-ff00008c97d0

Qualified Person (QP)

Qualified Person (QP)

Qualified Person (QP)

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 companies to develop, manufacture and supply life-changing therapies to patients.

We are seeking to hire a Qualified Person to support our rapidly growing business. This is an exciting role for a highly motivated individual to join a growing organisation and to be deeply involved in driving Quality Assurance and compliance activities within the company. The successful candidate will have the opportunity to work with a variety of clients and industry leading technologies to support the treatment of patients, including those suffering from rare and orphan diseases.

 

Responsibilities:

  • Fulfilling the role of the Qualified Person within the company and for clients in accordance with EU Directives 2001/83/EC.

  • Certifying Medicinal Products for use in the EU and outside the EU (where relevant).

  • Reviewing Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorization as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU, 536/2014 and EudraLex Volume 4, Annex 13 and 16.

  • Participate in Continuous Professional Development (CPD) initiatives with a view to maintaining, developing and broadening knowledge and skills as they relate to the function of Qualified Person.

  • 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 project lead/point of primary contact for clients.

  • Advising and providing input to clients’ quality management systems.

  • Undertaking audits in the EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.

  • Providing advice and guidance to the company’s staff and clients regarding QP requirements within the EU.

  • Participating in cross-functional projects for the development and scale-up of products.

  • Reporting directly to the Quality & Compliance Lead on a regular basis to ensure clients’ 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.

  • Undertaking departmental tasks and projects outside of the job holder’s direct area of responsibility, in line with departmental and senior management team objectives.

 

Requirements:

  • Third level degree in Science or relevant discipline.
  • Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives 2001/83/EC and 2001/20/EC//536/2014 respectively.
  • Minimum 5 years of experience in the pharmaceutical industry in a Quality role, with at least 1 year experience as a releasing QP.
  • Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
  • GMP auditing experience of suppliers in pharmaceutical industry.
  • Collaborative team player with a positive attitude and the ability to think and act quickly to identify creative solutions to complex problems.
  • Strong judgment and decision-making skills.
  • Experience in aseptic processing, sterile manufacturing or cell and gene therapy manufacturing is desirable.
  • Direct experience in participation in regulatory audits.
  • Direct experience in development and oversight of Quality Management Systems.
  • Excellent time management and project management abilities.
  • 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.
  • Some travel is required to support this role e.g., GMP audits. Approximately 10% of time.

 

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

Working hoursWorking hours will be 9-5.30 daily. The nature of the work may require flexibility in working times.

Location:

The role will preferably be based in the greater Dublin area, however other locations will be considered as remote work is possible. The QP will be expected to be present on site in HTH’s Dublin office when performing batch certification duties.

Recent News

PMTC Spotlight – HiTech Health

HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight.   HiTech Health is a full-service Contract Development and Manufacturing...

Stay Up To Date

Connect with us to receive the latest HiTech Health and industry updates.