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 GMP clinical manufacturing of advanced therapeutics and aims to transform the time and cost associated with producing medicines for our clients.
This will be the first Irish-owned facility expressly designed to provide Ireland and Europe with a local supply chain for these critical medicines.
To create the best client experience, we are creating and implementing a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver as a Medicine Accelerator. This is a unique opportunity for the successful candidate to become involved in ATMP and related pharmaceutical developments.
The work we do is unique, and our coexistence with APC on our campus provides incredible opportunities to learn from and collaborate with our APC colleagues, both technically and personally, in a shared modern and exciting cultural environment, making VLE Therapeutics a great place to work.
Principal Responsibilities
1. Ownership to develop the Quality Control requirements for VLE GMP manufacturing operations, including testing requirements, sampling plans, engagement with outsource QC suppliers.
2. Execution of process, environmental, and facilities monitoring, sampling, and testing in line with GMP manufacturing needs.
3. Develop and execute required documentation to support QC (SOPs, Test methods, sampling plans, CoAs, LIR, Protocols, Reports) and review of analytical data.
4. Provide laboratory support across the organization through collaboration with scientists and engineers, ensuring GMP/GLP standards are maintained.
5. Collaborate with VLE team members at relevant meetings and proactively communicate issues.
6. Support investigation of analytical failures or out-of-specification results using structured problem solving and root cause analysis, implementing corrective actions.
7. Develop and evaluate analytical training programs and train new laboratory personnel.
8. Assist with project management of VLE analytical activities and identify improvement projects.
9. Set up, use, and maintain analytical equipment and systems (e.g., LIMS, LabX, UV software).
10. Assist with laboratory 6S and maintain good housekeeping.
Essential Experience & Qualifications
1. QC Operations professional with GMP Pharma experience (minimum 2 years).
2. Ability to perform QC activities in a cGMP manufacturing environment.
3. Primary Degree in a scientific discipline or equivalent.
4. Relevant post-graduate qualification is an advantage.
5. Demonstrated ability to operate within cross-functional teams.
6. Effective organizational skills and ability to self-direct.
How To Apply
Suitable applicants should submit a CV and Cover Letter. The closing date for applications is 31st May 2025.
VLE is committed to equal opportunity employment. All decisions are based on business needs, job requirements, and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity, marital status, or any other protected status under Irish law.
Salary
Negotiable
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