- Reference: 42807
- Job Type: Permanent
- Location: Longford, Offaly, Westmeath
- Category: Science, Pharmaceutical & Food
Analytical Scientist: Start up environment – Career Opportunity to join a progressive and dynamic organisation.
This is a unique opportunity to join a thriving organisation currently in the process of developing a number of life changing biologic products to for the market.
This role within the Development group will support the development and validation of analytical test methods used for in-process and final product testing of recombinant antibodies use. The position involves the development of new bioanalytical methods to support the overall product development programme. The role will also involve interacting with external contract testing service providers.
- To support the development, optimisation, and validation of analytical test methods either in-house or in collaboration with external service providers
- Support the technical transfer of the analytical test methods from external partners to the new facility
- Write test method and validation protocols, SOPs, and other quality system documentation to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations
- Work closely with the process development group to support the development of a robust manufacturing process and transfer to the GMP facility
- Work closely with specialist contract testing service providers to ensure excellent collaboration is maintained throughout the project
- Support raw material testing when required for GMP manufacture
- Input into the identification of equipment requirements and work with vendors to ensure execution of all deliverables including equipment qualification and validation
- Provide technical reports on completion of development and validation tasks
- Participate in Quality and Safety regulatory audits
Qualification and Experience:
- BSc, MSC in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent experience
- 5 years relevant experience in development / validation of bioanalytical test methods
- Experience of the tests methods commonly used in the analysis of proteins, including but not limited to, ELISA, HPLC, Capillary Electrophoresis, MS, Glycan analysis, potency methods
- Qualification / Validation of test methods
- Proven ability to work independently in a laboratory
- Ability to learn quickly and take responsibility for tasks/projects
- Highly organised and structured approach to task completion
- Excellent verbal and written communication skills. Including ability to present work in clear, concise reports or presentations
For a confidential discussion and or more information on the role and organisation , please contact Mary Mullin on 09064 78104 /085 8718281 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos!