This innovative global biotech organisation is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology pioneer since 1980, this business has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Due to continued expansion a new position has arisen at the site for a individual contributor sitting at Senior Manager providing bioanalytical expertise to the site with regards to method transfer, troubleshooting, investigations and some method development.
- Technical leadership in support of troubleshooting method related issues, incoming method transfer and commercial investigations
- Independent authorship technical reports and answers to analytical questions from health authorities
- Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterisation/optimisation, investigations, and regulatory submissions
- Generating, analysing, and critical evaluation of analytical data to support product development investigations, and regulatory submissions
- May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
- Provides mentoring and expertise to less-experienced staff
- Duties may include establishing timelines, milestones, methodological approaches, expected results, and necessary resources
- Keeping current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities
- Doctorate degree in life sciences or related discipline and 2 years of scientific experience OR master's degree in life sciences or related discipline and 5 years of scientific experience OR bachelor's degree in life sciences or related discipline and 7 years of scientific experience
- Proven technical leader with advanced understanding and experience with various analytical platforms such as chromatography, CE, general assays (e.g. pH, osmolality, Karl Fisher titration, etc.), gels, bioassays and immunoassays
- Experience in developing, implementing and commercialising methods for in-process, process characterisation, and release testing
- Experience with method qualification/validation
To learn more about this role apply online or call Shane Browne on + 353 1 6321865 for a confidential discussion.