Ireland | Permanent full-time role & flexible working conditions
HiTech Health is a Contract Development and Manufacturing Organisation (CDMO) for advanced medicines including cell and gene therapies. The company was established in 2013 in Dublin, Ireland, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports healthcare companies globally from the development to the launch and supply of products.
We have an opportunity for a highly motivated team-player to join our growing organisation, working as a Biopharmaceutical Project Manager. The role will involve supporting a diverse range of clients as they progress products from development through to supply to patients. The candidate will lead projects within a multi-disciplinary team environment.
Responsibilities:
Effectively lead projects, particularly in the area of advanced medicines, from initial client briefing through to execution and completion within a highly regulated environment.
Ensure that project tasks are controlled and executed, as well as project goals are delivered on time, within budget, to specification and meeting the highest standards of quality.
Supporting clients with supply chain and logistics requirements in line with Good Distribution Practice (GDP) guidelines.
Participate in cross-functional projects, working closely with other departments (QA and Regulatory etc.) for the development and scale-up of products, ensuring compliance with EU and US regulations.
Communicate progress to business and technical stakeholders throughout projects. Reporting directly to the Managing Director on a regular basis to ensure client’s goals are being efficiently met in line with quality and compliance standards.
Optimally use innovative business processes to support the launch and supply of products to patients.
Monitor and report the project’s progress, identify and control any risks to the project’s schedule or commercial objectives.
Requirements:
A degree in an Engineering or Science area is required at minimum (preferably Biotechnology, Bio/Chemical or Biomedical Engineering).
Minimum 3 years of experience in a life sciences industry.
Excellent working knowledge of Drug Substance and Drug Product processes.
Understanding of quality systems, FDA and EU regulations, cGMP and ICH guidelines.
Experience in people management is favourable. Ability to critically assess situations and make strategic decisions.
Excellent time management and project management abilities. A project management Certificate is desirable.
Outstanding written, verbal and interpersonal communication skills, presentation skills and the ability to effectively interact cross functionally.
Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
Willingness to support and contribute to other business areas as requested.
Travel to support clients may be required while meeting Covid-19 regulations.
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 email your CV to jobs@hitech-health.com with your CV and referencing the job role in the subject line.
Location: Discussed upon interview
We reserve the right to re-advertise or extend the closing date for this job post.
The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
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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
Hitech Health’s Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate’s Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for developers, investors and solution providers whose goal is to bring cell and gene therapies to patients. We are really looking forward to the event and will be available for partnering meetings to discuss how we can help your advanced therapy processes and reach your goals.
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head of Commercial for Hitech Health, effective 1st December 2022. In this role, Clare will lead the Business Development and Marketing for Hitech Health, providing the full Contract Development and Manufacturing Operations (CDMO) services for Cell and Gene Therapy Drug Development.”
Brian adds: “Clare has over 20 years industry experience and has held various roles in QA, QC, Regulatory Affairs as well as Operational Leadership. The majority of her experience has been in clinical drug development with an additional 2 years spent working in a GMP setting. Most recently she led the global Business Development teams for two divisions of a Global CRO.”
The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in 20221. The US Food and Drug Administration (FDA) expects that they will receive more than 200 investigational new drugs (INDs) per year, building on the more than 800 active cell therapy or directly administered gene therapy INDs currently submitted to the FDA2. The diverse and complex nature of CGTs can often make regulatory affairs matters more intricate than traditional pharmaceutical products.
To meet the demand for advanced medicines, the FDA announced in the Federal Register that the Office of Tissue and Advanced Therapies (OTAT) in the Center for Biologics Research and Evaluation (CBER) has been changed to the Office of Therapeutic Products (OTP) and upgraded to a “Super Office” that should significantly improve the efficiency of the workflow for reviewing regulatory submissions. This will include therapeutic tissue-engineered products, human cell and tissue products and combination products, as well as gene therapies that result in persistent cellular modifications.
This initiative has also received significant financial support from the US Congress. More products will be able to be reviewed and supported by the knowledge of more scientific experts, which should help companies to launch their products in a timely manner. Advanced medicines such as CGTs are often intended to meet unmet medical needs and the steps taken by the FDA are a positive move to ensure patients receive life-changing treatments.
To learn more about our cell and gene therapy services by clicking here:
