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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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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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 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: 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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QA Specialist

QA Specialist

QA Specialist

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 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.

This is an exciting role for a highly motivated individual to join a growing organisation to work as a QA Specialist for our expanding laboratories in Galway. The candidate will work closely with clients and other functional units within Hitech Health including production to support the development and manufacture of a range of cell and gene therapy products, as well playing a key role in the growth of HiTech Health.

 

Responsibilities:

  • As QA Specialist, you will be responsible, with support from management, for providing general Quality support for key functional areas (i.e. Process Development (PD), Validation, Quality Control, Supply Chain, Quality Assurance, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory expectations and local requirements.
  • This permanent position is an exciting role for a dynamic individual to join a growing organisation, focused on the Cell & Gene Therapy space.
  • The QA Specialist reports to the Quality & Compliance Lead. The QA Specialist will work across HiTech Health’s GMP and PD functions.

 

Principle Responsibilities:

  • Review and approve PD batch records against approved specifications, quality standards and company procedures for release of product on behalf of HTH clients.
  • Review GMP batch records against approved specifications, quality standards, company procedures and regulatory filings prior to review and certification by HTH QP.
  • Write and/or review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols).
  • Lead and/or participate in quality risk assessments and provide quality oversight to ensure risk assessments are effectively executed.
  • Maintenance of HiTech Health Quality Systems including Training, Change Control, Deviations, CAPA, and Supplier qualification.
  • Assist in the investigation and closure of investigations, Deviations and Out of Specifications.
  • Ensure non-conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s.
  • Perform QA review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
  • Provide support for regulatory and customer inspection readiness, execution and follow up.
  • Participate in internal audit and program.
  • Lead HTH documentation management system and documentation control requirements.
  • Act in accordance with the company’s Guiding Principles and adherence to the company Code of Conduct.
  • Compliance to all local site policies, procedures and Environmental, Health and Safety regulations.
  • Perform additional duties as required.

 

Qualifications and Experience:

  • Third level Degree in biology, chemistry, pharmacy or other relevant discipline.
  • 3-5 years’ experience in Pharmaceutical industry in a Quality role (or equivalent).
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and GMP regulatory requirements.
  • Experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems required.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • High level of proficiency in English language (both spoken and written) required.
  • 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
  • Thorough, diligent, good attention to detail.
  • Results driven and creative with a can-do attitude.

 

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: 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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