Analytical Validation Scientist
Our client, a high profile Shannon based biotech organisation, are now experiencing significant growth across all markets & looking to recruit a Analytical Validation Scientist to join their team & help support this new expansion.
This newly created role is a fantastic opportunity for an ambitious & suitably qualified candidate to further develop their career with one of the world’s most successful biotech companies so if you’re interested, please apply!
As an Analytical Validation Specialist, your role will be to be responsible for the validation and/or technology transfer of novel and established test methods for the analysis of gene therapy products and associated materials used for manufacturing to EU and FDA GMP requirements.
This role will be a part of aiding the start-up of a new GMP facility for the production of gene therapy products. As such, it will involve participating in and providing subject matter expertise in method transfer and validation.
- Ensuring own work complies with GMP, Data Integrity and Good Documentation Practices (GDP) and is undertaken in accordance with applicable procedures.
- Ensuring that own training is undertaken in a timely and GMP-compliant manner before tasks are begun.
- Ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.
- Development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
- Generate validation/transfer test protocols and subsequent reports.
- Ensure that method transfers and validations are fully executed in compliance with regulatory standards and that all data integrity requirements are met.
- Write, review and update SOPs and related documentation for QC, where required.
- Support the set up of the QC Analytical Labs at the Shannon site.
- Generate master Quality Control Analytical Record documents and implement post-validation.
- Manage workload so that agreed timelines are met to ensure no disruption to business.
- Communication with key stakeholders, relaying progress towards major milestones. Clearly and effectively outline any risks/issues in a timely manner to allow effective mitigation.
- Perform routine assessments of all analytical methods to confirm they are operating as expected.
- Provide Subject Matter Expertise as part of regulatory inspections and site audits.
- Support with maintaining the Quality Management System and controlling of documents and assuring the data integrity of all data produce.d
- Support with all reasonable managerial requests and ad-hoc tasks.
Qualification and Key Skill Requirements
- BSc in a scientific discipline e.g. Biochemistry, Chemistry.
- Minimum 3 years experience working in a GMP environment.
- Demonstrable significant experience in analytical method validation and/or transfer in the pharmaceutical (or other regulated industry) a must.
- Experience in working with any or numerous of the following methods preferred; qPCR, HPLC, ELISA, CGE.
- Proficiency in a body of information required for the role; e.g. knowledge of EU and FDA regulations, GMP/GLP/GDP, etc.
- Proficiency in Microsoft Office software preferred, specifically Word, Excel and PowerPoint.
Key Job Competencies
- Experience of working within a quality environment.
- Ability to work in a fast-paced environment essential.
- Problem Solving - Identifies and resolves problems in a timely manner; able to gather and analyse information; develops alternative solutions; works well in group problem solving situations.
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures.
- Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
- Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
If you have the above skills & experience please contact Darren Brown 087 405 3774 and email in confidence firstname.lastname@example.org