Biopharmaceutical Supply Chain Specialist

Biopharmaceutical Supply Chain Specialist

Biopharmaceutical Supply Chain Specialist

Galway, Ireland | Full-time, Permanent 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 dynamic and determined individual to join a growing organisation, to work as a Supply Chain Specialist supporting a diverse range of clients as they progress products from development through to commercial manufacturing and supply to patients. The candidate will lead and support projects, using their experience and expertise, to project manage the supply of new drug products and/or devices, as well playing a key role in the growth of HiTech Health.

Responsibilities:

  • Effectively lead projects, particularly in the area of biopharmaceuticals, 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 our clients with supply chain, RP activities and logistics in line with Good Distribution Practice (GDP) guidelines. Appropriate training will be provided.
  • 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.
  • Work closely with suppliers and subcontractors in satisfying our clients’ expectations.
  • Lead trouble-shooting activities and provide sustainable solutions for root cause processing problems.
  • Optimally use innovative business processes to support the launch and supply of products to patients, e.g., due diligence, risk assessments, change control, deviations, investigations, etc.
  • Monitor and report the project’s progress, identify, and control any risks to the project’s schedule or commercial objectives.

Essential Requirements:

  • An Upper Second-Class Honours in an Engineering or Science area is required at minimum (preferably Biotechnology, Biochemical or Biomedical Engineering).
  • Experience with new product development, product transfer/scale-up and introduction is expected.
  • Minimum 5 years of experience in the Biotechnology industry in product development/new product introduction roles.
  • 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.
  • Manage 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.
  • 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: To be confirmed – subject to successful candidate’s notice period.

To Apply:

Applications to include a cover letter, CV, and the contact details of two referees should be sent, via e-mail (in word or PDF only) to  recruitment@hrduo.com  and info@hitech-health.com

HiTech Health is an equal opportunities employer.

 

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

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CGT Technologist

CGT Technologist

CGT Technologist

Galway, Ireland | Full-time, Permanent role

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 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-culture based manufacturing and supply of cell and gene therapies.

Responsibilities:

  • Responsible for supporting production and testing operations in the new cell and gene therapy facility.
  • Become proficient on processes within the new facility and train other new hires.
  • Creation of SOPs to support the successful start-up and commissioning of the new facility.
  • Creation and execution of equipment qualifications and provide support to visiting engineers on site as required.
  • Aseptic processing of cells in line with GMP requirements, including filling and cryopreservation.
  • Maintain any batch records and production related records as required.
  • Creating and maintaining logbooks for equipment.
  • If required, supervise student interns and help co-ordinate their work activities.
  • Provide support in maintaining the cleanliness and EHS standards of the facility.
  • Complete incoming inspections on raw materials and components in line with controlled procedures.
  • Review and approval of raw material inspection records.
  • Help in collating, trend and presenting Key Performance Indicator (KPI) Data for the facility.
  • Test and optimise protocols for production and quality control of viral particles.
  • Responsible for authoring protocols, reports, WIs, SOPs and other relevant GMP documents.
  • Follow maintenance and cleaning SOPs, keeping work areas clean on a daily basis.
  • Order and restock supplies when required. Assist with managing incoming and outgoing materials as well as storage.
  • Support regulatory authority inspections and meetings with health authorities if required.

Essential Requirements:

  • Minimum MSc in a Cell and Gene Therapy related area.
  • Knowledge of cell culture-based manufacturing, technology transfer, investigations, and process validation of cell and gene therapies.
  • 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.
  • Familiarity of US and European GMPs and Pharmacopeia.
  • Excellent written and verbal communication and the ability to multi-task across multiple products and programs is highly important.
  • Excellent organizational skills and attention to detail.
  • Enthusiastic and self-motivated.
  • Able to manage multiple tasks efficiently.
  • Competent in using Microsoft Office.
  • Familiarity with sterile techniques.
  • Attention to detail and application of laboratory safety practices.
  • Ability and willingness to adapt to changing priorities and deadlines as well as contribute to other areas of the business.

Desirable Requirements:

  • Industry experience of working in a GMP manufacturing facility is highly desirable.
  • Experience with tissue culture and viral production is advantageous.
  • 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 9-5 daily.  The nature of the work may require flexibility in working times.

Start date: To be confirmed – subject to successful candidate’s notice period.

To Apply:

Applications to include a cover letter, CV, and the contact details of two referees should be sent, via e-mail (in word or PDF only) to  recruitment@hrduo.com  and info@hitech-health.com

Closing date for receipt of applications is 10/10/2021

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

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

Stay Up To Date

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

Office Admin

Office Admin

Office Admin

Dublin, Ireland | Part-time, Maternity Cover role

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.

We have an exciting opportunity for a highly motivated individual to work with a growing organisation and ensure that the administrative tasks and financial transactions are processed accurately and on time.

Responsibilities:

  • Inputting invoices and expenses.
  • Providing support for supplier billing enquiries.
  • Managing all supplier invoices.
  • Assisting with issuing PO’s.
  • Liaising with suppliers and handling queries.
  • General office duties (answering phone, filing, archiving, opening post, operate office equipment, supplies ordering, meeting scheduling etc.).

Essential Requirements:

  • Previous administration experience including knowledge of procurement would be an advantage.
  • Conscientious about deadlines.
  • Self-starter, detail-oriented; excellent organizational, time management and communication skills.
  • Experience in Microsoft Word, Excel & Outlook, Xero an advantage.

 

Start date: 1st of October 2021

Length of the contract: 6 months

Number of hours per week: 20-25 hours/week

To Apply:

To apply for this internship please email your CV and Cover Letter to alargean@hitech-health.com

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

Stay Up To Date

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

Quality Validation and Assurance Specialist – CGT – Galway

Quality Validation and Assurance Specialist – CGT – Galway

Quality Validation and Quality Assurance Specialist – Cell and Gene Therapy

Galway, Ireland | Permanent full-time role | Salary commensurate with experience

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.

We are seeking to hire a Quality Validation and Quality Assurance Specialist for our expanding laboratories in Galway. This is an exciting role for a highly motivated individual to join a growing organisation and be deeply involved in leading cGMP compliance and validation activities. 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.

Responsibilities:

  • Responsible for leading and executing Qualification and validation activities in a cGMP environment for key site processes, equipment and utilities and on-going process validation, in line with current regulatory requirements, corporate policies and site procedures (as per Validation Master Plans), including the generation/review of validation documentation (schedules/Risk Assessments/Protocols /Reports/Annual Reports/).
  • Presenting executed qualifications during internal and external audits.
  • Ensuring that a continuous state of validation is maintained for site equipment, systems and utilities, including providing validation input for site Change Controls.
  • Responsible for executing site periodic reviews and revalidation activities
  • Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments).
  • Participate in project teams and assist in determining project schedules and the appropriate levels of validation
  • Support the development of the quality plans for ensuring all regulatory requirements are met during the validation of equipment, facilities, utilities or systems
  • Ensure technical input and guidance on deviation investigations during qualification/validation activities in case of particular relevance or impact
  • Provide support to the local organization as validation SME and as a primary Point-of-Contact for the relevant Regulatory Agencies in occasion of Regulatory Inspections, Customer audits and for the relevant follow-up
  • 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 maintained/ controlled.
  • Assist in the investigation and closure of complaints, deviations and Out of Specification investigations
  • Ensure non-conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
  • Provide QA oversight and guidance on the evaluation and implementation of change controls
  • To participate in inspections by third parties, e.g. HPRA, FDA, customers, etc.,

Essential Requirements:

  • Minimum of a Bachelors degree in Science, Engineering, Technology or a related discipline.
  • Relevant experience as a QA validation engineer/specialist in a cGMP environment (3+ years).
  • Full understanding of cGMP requirements including Annex 11 and Annex 15.
  • Effective technical writing skills.
  • Experience of working in an aseptic manufacturing environment is desirable.
  • Good problem solving and investigation skills.
  • Good professional standards, meticulous and demonstrates good attention to detail.
  • Ability to work under pressure and meet deadlines.
  • Highly motivated self-starter and team worker.
  • Ability to work in a team-based environment and ability to manage a wide range of specific tasks.
  • Good organisational, coordination and communication skills.

 

TO APPLY, PLEASE CLICK HERE: https://my.hrduo.com/candidate-jobs/Hitech_Health_and_De%C3%A1ntusaiocht_Slainte_Hitech_Teoranta/816437823

FOR MORE INFO: recruitment@hrduo.com

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

Stay Up To Date

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

Research and Development Manager – CGT – Galway

Research and Development Manager – CGT – Galway

Research and Development Manager – Cell and Gene Therapy

Galway, Ireland | Permanent full-time role | Salary commensurate with experience

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.

We are seeking to hire a Research and Development Manager for our expanding laboratories in Galway. This is an exciting role for a highly motivated individual to join a growing organisation and be deeply involved in leading the development of new process and analytical methods. The candidate will work closely with clients and other functional units within Hitech Health including production to support the development of a range of cell and gene therapy products.

Responsibilities:

  • Lead a team of scientists focused on product development for the cell and gene therapies for our clients. This includes the training and development of the scientists for a growing company.
  • Design experiments independently and in multi-disciplinary teams to efficiently test hypotheses and rapidly iterate to ensure optimal solutions for clients.
  • Execute experimental plans individually and with the team.
  • Drives key initiatives including trouble-shooting Manufacturing challenges.
  • Manage projects within the portfolio through the development process and ready for transfer to GMP manufacture.
  • Lead the technical transfer from R&D/GLP into the GMP setting.
  • Generate new ideas to expand the product portfolio.
  • Proactively investigate and resolve problems, identifying root cause, and proposing process improvements.
  • Optimize cell selection, gene delivery, and culture protocols for cell and gene therapy applications.
  • Troubleshoot and optimize, develop alternative methods, and innovate.
  • Document and analyse data and manage the R&D documentation in line with company and client requirements.
  • Foster collaboration and team building, liaise with other business functions and clients to successfully transfer products.
  • Coach and mentor scientists, remove roadblocks and create a highly functional team.
  • Communicate with client companies including the development or project proposals, project status updates and reports.
  • Stay up to date on new developments and regulations in the cell therapy field by studying the literature, attending conferences, and conversations with key opinion leaders and consultants.
  • Lead in documentation for reports for clients and also for regulatory documentation filings.
  • Create SOPs and Quality Control specifications based on the data obtained from R&D.

Essential Requirements:

  • MSc or Ph.D. in Science, with a focus on Cell and Gene therapy research and development.
  • At least 6 years experience in a Cell and Gene therapy company in a Research and Development environment and including the management of a team of scientists.
  • Strong knowledge of cell culture-based manufacturing, technology transfer, investigations of cell and gene therapies.
  • Experience with manufacturing of cellular therapy products and viral production.
  • Hands-on technical experience in all or most of the following; flow cytometry, Bioreactor technology, virial vector manipulation, RT-PCR/Q-PCR, Gel analysis, ELISA.
  • Familiarity of US and European GMPs and Pharmacopeia.
  • Proficient in technical writing and experience in creating R&D process documents; Analytical Development documents; Technical Transfer documentation and summary reports to support FDA and EMA filings.
  • Experience working in a small-medium company and/or facility start-up.
  • Knowledge of emerging technologies, trends, and methodologies.

 

TO APPLY, PLEASE CLICK HERE: https://my.hrduo.com/candidate-jobs/Hitech_Health_and_Deántusaiocht_Slainte_Hitech_Teoranta/816759042?tracker=LinkedIn

FOR MORE INFO: recruitment@hrduo.com

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

Stay Up To Date

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