HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA

HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA

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.

 

Schedule a meeting with our experts today: info@hitech-health.com

 

Learn more about our services here: www.hitech-health.com

 

Microbiologist – Cell and Gene Therapy

Microbiologist – Cell and Gene Therapy

Microbiologist – Cell and Gene Therapy

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 Microbiologist for a new cell and gene therapy facility in County Galway. This is an exciting role for an aspiring professional to join a growing organisation to work on all microbiological matters within the cell and gene therapy division of HiTech Health. The candidate will work closely with the production team and quality function to support the manufacturing and testing of a range of cell and gene therapy products.

 

Responsibilities:

  • Authoring microbiological related plans, protocols, reports, SOPs and other relevant GMP documents.
  • Oversee the generation of Work Instructions (WIs) and Standard Operating Procedures (SOPs) as pertains to microbiological activities.
  • Performing environmental monitoring performance qualifications and routine environmental monitoring programs.
  • Performing laboratory-based assays, such as but not limited to growth promotions, gram staining, colony counting, microbial Identification Assays, sterility testing, endotoxin testing etc.
  • Subject matter expert and lead in all microbiological related Out of Specification (OOS) or Out of Trend (OOT) analytical results, deviations, investigations, corrective or preventive actions
  • Contribute to aseptic process simulations/media fills as required.
  • Train others in laboratory procedures where required and execution of analytical testing for microbiology requirements to support any QC, R&D or Manufacturing activity.
  • Assist at regulatory authority inspections and meetings with health authorities if required.

 

Essential Requirements:

  • Minimum of Honours Bachelor’s degree in a relevant discipline (Microbiology, Biology, Chemistry or similar).
  • A minimum of 3 years Microbiology experience in a GMP facility.
  • Thorough knowledge of US and European GMPs and Pharmacopeia.
  • Expertise in contamination control of GMP cleanroom facilities.
  • Subject matter expert with practical experience of environmental monitoring testing and product testing (e.g. sterility, mycoplasma, endotoxin).
  • Attention to detail and application of laboratory safety practices.
  • Excellent written and verbal communication and the ability to multi-task across multiple products and programs is highly important.
  • Proficient in technical writing and experience in creating; SOPs, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.

 

Desirable Requirements:

  • MSc qualification in a relevant subject area is desirable.
  • Experience in cell culture based manufacturing and molecular techniques, including polymerase chain reaction and sequencing, is highly 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.

Applications to include a cover letter & CV. References should be made available upon request.

Location: Co. 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.

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Hitech Health Appoint Clare O’Sullivan as Global Head of Commercial

Hitech Health Appoint Clare O’Sullivan as Global Head of Commercial

Global Head of Commercial

Global Head of Commercial

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.”

 

Email info@hitech-health.com to speak with our team today.

New FDA ‘Super Office’ created for Cell and Gene Therapy Products

New FDA ‘Super Office’ created for Cell and Gene Therapy Products

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:

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Contact: info@hitech-health.com

 

References:

  1. Young CM, Quinn C, Trusheim MR – September 2021 – Durable cell and gene therapy potential patient and financial impact: US projections of product approvals, patients treated, and product revenues – https://www.sciencedirect.com/science/article/pii/S1359644621003901
  2. S. Food & Drug Administration (FDA) – January 2019 – https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics
  3. The Science Advisory Board – October 2022 – https://www.scienceboard.net/index.aspx?sec=ser&sub=def&pag=dis&ItemID=4803

 

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 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.

Applications to include a cover letter & CV. References should be made available upon request.

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.

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