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QC Technician - VLE Therapeutics (Full Time)
QC Technician - VLE Therapeutics
About VLE Therapeutics
Powered by transformation research in APC, VLE Therapeutics Ltd was formed to extend the value chain and deliver science and digital led manufacturing of Vaccines and Advanced Therapeutics. VLE Therapeutics will support the GMP manufacturing of clinical and commercial vaccines, next generation biologics & advanced therapeutics and aims to transform the time and cost associated to produce medicines for our clients.This will be the first Irish-owned facility expressly designed to provide Ireland and Europewith a local supply chain for these critical medicines.
To create the best client experience, we will create & implement a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver a Molecule-2-Market accelerator.
Stage 1 - At our current APC facility, we are constructing a new state of the art biomanufacturing facility. Operations will employ cutting edge technology including single use equipment & disposables and deploy digital solutions to support the best client experience.
Stage 2 - In parallel, we are planning the development of a bespoke 80,000ft2.
greenfield GMP manufacturing facility, which will provide a world-class platform for the manufacture of a wide range of vaccines next generation biologics & advanced therapeutics for our clients globally.
Key to enabling our strategy is to create the best culture, the right values & behaviours and as a result, the establishment of a high performing team committed to creating a culture of excellence in everything we do.
The role will involve looking after the Quality Control needs of the VLE Therapeutics start-up business. This role within a start-up situation is very exciting and changing in that the personal characteristics of flexibility, initiative and teamwork are required to make the role and the work that you do meaningful. The QC technician will support the GMP Manufacturing Facility with emphasis on microbiological testing such as Environmental Monitoring, Water, Gas, Bioburden and Endotoxin.
- Demonstrate high performance behaviours, ability to work collaboratively within a cross functional team, ability to show independent initiative, to have a focus on continuous improvement and have a strong belief in supporting the right culture in the business.
- Execution of process, environmental and facilities monitoring, sampling, and testing is completed in line with GMP manufacturing needs.
- Testing to support release and stability programs
- Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
- To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
- Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
- To keep management updated on issues arising within the laboratory.
- Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
- To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.
- Ownership to develop the Quality Control requirements for VLE GMP manufacturing operations, including testing requirements, sampling plans, engagement with outsource QC suppliers.
- Develop and execute required documentation to support QC (SOP’s, Test methods, sampling plans, CoA’s, LIR, Protocols, Reports) and completion of required analytical data review.
- Provide laboratory support across the organisation through collaboration with scientists and engineers, both internally and externally, ensuring GLP standards are maintained at all times.
- Collaborate with the VLE team members at relevant meetings and proactively communicate with the team members and/or departments on issues.
- Support investigation of analytical failures or out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
- Development & ongoing evaluation of analytical training programme and the training of any new laboratory personnel.
- Assist with project management of VLE analytical activities and proactively identify & implement improvement projects.
- Set up, proper use and maintenance of relevant analytical equipment and systems (e.g., LIMS/LabX/UV software)
Experience & Qualifications
- Minimum of 1-3 years experience in cGMP Quality environment.
- Experience in testing of sterile & non-sterile biopharmaceutical products.
- Experience in sampling of environmental, facility & utility systems
- Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
- Drug Substance Biologics experience is preferable.
- Vaccine manufacturing experience is preferable.
- Advanced Therapeutics (Cell & Gene Therapy) manufacturing experience is a positive.
- Experience in QMS Processes, systems, and procedures
- The role may operate on rotating shift position and may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend process operations.
- Must be able to read, write and converse in English.
- Must have good working knowledge of MS Excel and Word
- Ability to work in an intense, fast-paced work environment.
- Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously.
- Ability to work independently and as part of a team.
- Degree in Microbiology or related science discipline
How to apply
Suitable candidates should submit a CV and a Cover Letter
VLE is committed to the principle of equal opportunity for all employees. All employment decisions at VLE are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, marital status, or any other status protected by Irish law.
Similar vacancies arising in the coming 6 months may be filled from this group of applicants.