HiTech Health are delighted to have an article entitled ‘Cell and Gene Therapy Manufacturing Considerations for Early Stage Companies’ published in distinguished publications, cellandgene.com and outsourcedpharma.com. The article should be of benefit to companies who are looking for a partner to develop and manufacture their clinical products.
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.comand indicate theposition titlein 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 are delighted to have an article entitled 'Cell and Gene Therapy Manufacturing Considerations for Early Stage Companies' published in distinguished publications, cellandgene.com and outsourcedpharma.com. The article should be of benefit to companies who...
Over the past decade, the regenerative medicine landscape has undergone an extraordinary evolution with the continuous growth of Advanced Therapeutic Medicinal Products (ATMPs). ATMPs are medicines for human use that are based on genes, tissues or cells. They treat...
IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech...
Ireland | Permanent full-time role & flexible working conditions
HiTech Health (HTH) focuses on enabling healthcare companies to launch and supply products. 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, HTH supports healthcare companies from the development to the launch and supply of products. HiTech Health is authorised by the Health Product Regulatory Authority (HPRA) to manufacture small volume sterile and ATMP products as well as to perform batch certification of both commercial and investigational medicinal products.
This permanent position is an exciting role for a dynamic individual to join a growing organisation. The successful candidate will have the opportunity to work with a number of clients and to contribute to a variety of different projects. The role will primarily be based at HTH CDMO facility in Galway.
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 are delighted to have an article entitled 'Cell and Gene Therapy Manufacturing Considerations for Early Stage Companies' published in distinguished publications, cellandgene.com and outsourcedpharma.com. The article should be of benefit to companies who...
Over the past decade, the regenerative medicine landscape has undergone an extraordinary evolution with the continuous growth of Advanced Therapeutic Medicinal Products (ATMPs). ATMPs are medicines for human use that are based on genes, tissues or cells. They treat...
IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech...
Temperature is a critical parameter in the transportation and storage of medicinal products. The temperature must be controlled and monitored from the manufacturing site through to the distributor and site of medicine use. When temperatures go outside the specified range, there is a risk that the medicine may alter and degrade with the potential for adverse outcomes for the patient. In addition to this, there may be significant financial losses for the medicinal product owner.
The manufacturing of medicinal products is highly regulated with strict GMP quality control standards to ensure that a high-quality medicine is provided to patients. When it comes to transportation, it is just as important to maintain the same level of quality standards and ensure medicinal products are not compromised during the many touchpoints that can occur between the sending and receiving sites. Good Distribution Practice (GDP) is a set of standards, guidelines, and principles for the storage and transportation of pharmaceutical products. Developers must implement robust processes to guarantee the quality and safety of their products during distribution. GDP compliance can help avoid major quality impacts and potential product recalls.
Medicinal product shipments can generally be categorised as:
Ambient (controlled room temperature, 15°C to 25°C)
Refrigerated (2°C to 8°C)
Frozen (Below 0°C)
Cryogenic (Below -150°C)
As transportation may involve many modes of transport including road, air and sea, then continuously controlling and monitoring temperature can be challenging. Furthermore, cross border customs checks can cause unwanted delays. There is a risk that custom checks can interfere with outer packaging and cause exposure of the medicinal products to outside temperatures. The sensitivity of new advanced therapies such as cell and gene therapies increase the demand on both the shipping system and on the integrity of the entire temperature-controlled supply chain.
The FDA’s 21 CFR Part 11 guidance addresses the traceability challenges of electronic temperature records. Records must be reliable and accurate to ensure the quality and safety of the medicinal product. Pharmaceutical companies are strongly advised to use calibrated temperature monitoring dataloggers that can generate accurate and reliable reports. In addition to this, electronic records of all alarms and events must be kept.
With so many variables in transportation, successful shipments depend on reliable transportation and the correct choice of shipping system for the type of medicinal product. Using shipping systems that are validated and appropriate for the medicinal product is crucial. Performing shipping qualification studies is advised to ensure that a system is in place for seamless transportation and quality assurance.
To help navigate the challenges with temperature control, it is key to find partners experienced in handling complex medicinal products. HiTech Health have a team Responsible Personnel (RPs) who are specialists in GDP and can advise and support you with:
Minimising supply chain risks and ensuring compliance with applicable regulations
Shipping qualification studies
Due diligence and auditing of transportation providers
We can work with your team to ensure that effective processes are established to ensure that high quality medicinal products are available for patients on time.
Schedule a call with our team today to learn more about our services and how we can support your organisation.
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of experience managing Quality aspects of product and process development, to successfully release CGT product to clinical trials or to market in the EU, US, UK, and RoW.
QP batch release is required to be in accordance with EU requirements (Commission Delegated Regulation (EU) 2017/1569 and Regulation 536/2014) on Investigational Medicinal Products (IMP) covering both sterile and non-steriledosage forms. QP and Quality Services offered by Hitech Health include contractual QP services, for both general Quality consultancy and batch release, for short and long-term contracts.
The QP and Quality Services include:
Supporting and maintaining all aspects of Quality Management System (QMS) compliance.
Designing and implementing a robust supplier qualification program and effective management of this process.
Importation and QP Certification.
With Hitech Health holding the Manufacturer’s/Importer’s Authorisations (MIAs) for the importation and QP certification of both Commercial and Clinical products within the EU, CGT products can be imported and released to EU clinical trials in a matter of months.
Hitech Health has QPs specialising in the CGT and ATMP field and can offer quality support for the successful release of your CGT product. By partnering with us and working with our experienced cross-functional team under our already approved MIAs, you reduce personnel and regulatory cost, thereby making considerable financial and time savings in getting your product to the clinic or market.
To learn more about our cell and gene therapy services by clicking here
