Description
Global Healthcare Company is seeking a senior chemist to join their team in their brand new state of the art facility in Dublin.Day to Day:
- Work with cross functional teams within the company to provide analytical support for all product development activities supporting regulatory submission and product commercialization.
- Analytical SME who works with the product development and technical transfer groups to design experiments, perform analytical testing and interpret analytical results in line with protocol objectives
- Work with the stability group within the company to design and execute stability protocols that meet regulatory requirements to support shelf life assignment for clinical studies and commercial product.
- 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.
- Compilation of technical documentation including test methods , protocols and reports to support regulatory submission, product and process understanding and technical transfer activities
- Identify gaps in product and process understanding and contribute to design of DOE to build on product knowledge.
- Review and approval of analytical data in line with study objectives
- Maintain a high standard of GMP ensuring audit readiness at all times ensuring the analytical group contributes to successful IMB and FDA audits
- Perform EHS training and responsible for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform analytical tasks
Requirements:
- 4+ years' experience in an analytical role within the pharmaceutical sector in a FDA or IMB accredited laboratory
- Ability to provide analytical and technical expertise to support product development and submission activities
- Ability to take ownership and execute analytical studies with minimum supervision
- Strong Technical writing skills with respect to protocol/report writing, batch record and SOP writing
- Experience of root cause analysis/investigations and problem solving to support analytical investigations
- Experienced in interpretation of analytical data
- An understanding of the requirement to meet project and team orientated goals and the ability to create win-win relationships with other functions to meet these goals.
- Knowledge and Experience in Inhalation testing
- Participation in analytical and/or process tech transfers
- Compilation of regulatory submissions
To hear more about the company team and role please contact me Anna Mooney or reply below with an up to date CV.