Description
Global generic and specialty pharmaceutical company based in North Dublin is seeking a Chemist to work within the Product development and technical transfer groups. This is permanent role with an attractive salary and benefit package on offer with this role.Day to Day:
- Work with the product development and technical transfer groups to design and execute experiments, and interpret analytical results in line with protocol objectives
- Work with cross functional teams within the company to provide analytical support related to clinical supplies, formulation development, stability, and process scale up. Responsible for manufacturing and testing of development, clinical and scale up batches in line with required GMP practices and quality procedures.
- Technical writing of protocols and report to support submission , product and process understanding and technical transfer activities
- Work with product development group to build up product knowledge by testing input materials and finished product, Identify gaps in product and process understanding and contribute to design of DOE to build on product knowledge.
- Maintain a high standard of GMP ensuring audit readiness at all times ensuring the product development group contributes to successful IMB and FDA audits
- Ensure high standards of safety and compliance with safety procedures at all times.
- Support laboratory equipment qualification process as required
- Perform analytical investigations and participate in laboratory and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™. Troubleshoot instrumentation and investigate aberrant sample results.
- Verify paperwork and documentation from other analysts including empower sign-off and LIMS review of clinical and development batches. Completion of all relevant laboratory testing documentation using right first time principles.
Requirements:
- Minimum of 3 years relevant experience or equivalent educational experience
- Knowledge and expertise in inhalation product development
- Experience in the compilation of technical documents including SOPs , development protocols and reports , test methods and specifications
- Positive attitude to work, ability to learn quickly and strong team-working skills
To hear more about the company and role its self-please apply below with an up to date CV.