A fantastic opportunity has arisen for an analytical scientist to join our Supply Analytical Sciences (SAS) team based in Ballydine. The successful candidate will join team as a senior scientist supporting small molecule drug substance supply in our company and external partner manufacturing sites in Europe.
Responsibility
- Provide comprehensive and scientifically appropriate analytical test methods to address quality requirements for release of pharmaceutical materials to be used for market supply.
- Support/Leads the development and optimization of reliable, validated, analytical methods to characterize the quality attributes of drug substances.
- Assures that right information on the quality of raw materials and in-process control points is provided to support process optimization studies with a clear linkage to regulatory filing requirements.
- Manages change control for analytical methods and specifications for assuring the quality of drug substances for inclusion in the regulatory submissions.
- Provides the analytical information for filings and responses to questions from regulatory agencies.
- Leads the transfer of analytical methods, specifications and development knowledge for the drug substance associated manufacturing process.
- Establishes relationships with partner scientific groups that facilitate a clear understanding of analytical issues and product supply.
- In partnership with the Quality organization, formulates and continually updates appropriate GMP procedures for analytical methods.
- Work with teams of scientists to effectively coordinate and support analytical method execution in a compliant manner.
Qualifications, Skill & Experience Required
- Qualification (BSc, MSc, or PhD) in science with experience of analytical chemistry techniques.
- Effective communication skills and ability to work as part of cross functional team.
- Outstanding critical thinking skills.
- Ability to work in an interdisciplinary team environment.
- Strong verbal and written communication skills.
- Experience in small molecule analytical development or quality control analytical testing,
- BSc minimum 4 years of experience
- MSc minimum 3 years of experience
- PhD minimum 1 year of experience
Preferred:
Extensive experience in analytical technology transfers.
As a company we are committed to flexible working where possible, and therefore our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model
