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Bioprocessing Technologist - VLE Therapeutics (Full Time)
Bioprocessing Technologist - 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 Europe with 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.
A key member in supporting the execution of cGMP operational activities in VLE Therapeutic’s manufacturing facility. The role will involve looking after the Manufacturing operations 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.
- 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.
- SME for technical issue troubleshooting / investigations / resolution
- Lead / implement operational processes and readiness activities
- Lead production scheduling, modeling & optimisations
- Support development / implementation of new tech transfer 'handover' processes from APC to VLE
- Lead / implement Opex and Lean Manufacturing programme
- Lead / implement Error Reduction programme
- Support implementation of digital roadmap and data analysis capabilities
- Lead development of training and knowledge management programme.
- Generation, management and updating of Procedures & Training documentation required to enable Manufacturing.
- Generating risk assessments for the introduction of a new process
- Support inspection readiness activities and related audits.
- Support / lead key meetings on behalf of Operations, including management of KPI Dashboard.
- Support / lead key functional and strategic projects as required to drive & grow the business.
Experience & Qualifications
- Manufacturing Operations professional with cGMP Pharma experience (1-3 years' experience).
- Drug Substance Biologics manufacturing experience is preferable.
- Vaccine manufacturing experience is preferable.
- Advanced Therapeutics (Cell & Gene Therapy) manufacturing experience is a positive.
- Aseptic operations experience is preferable.
- 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
- Demonstrate adequately and professionally the escalation of issues / develop solutions that may jeopardize manufacturing deliverables on a timely basis. Ability to maintain a constant communication with other team members.
- Ability to enable Lean Transformation and Operational Excellence initiatives and utilize tools to continuously improve staff and the line performance.
- Exhibits Professional approach to internal and external stakeholders.
- 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 a scientific discipline or equivalent experience preferred.
- Qualification in Lean / Opex systems is preferable.
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.