Analytical Research Chemist
3 weeks ago
The Analytical Chemist will function as a key member of the Process Development Service Team. You will be responsible for providing analytical expertise and technical support for all phases of drug development. This will include supporting the analytical aspects of route development and proof of concept of new and existing manufacturing routes for APIs. You will focus on the development of analytical methods for ad hoc investigations and process development. You will be expected to work as part of a team and across functions, while doing so you would be expected to review current practices with the target of using Practical Process Improvements (PPI) to help identify improvements and business cost savings.
What will you do?
Provide technical expertise and analytical support for the introduction of new products to the Cork site, including method development. At times it will be necessary to support the Analytical Development group prior to method validation. Lead the troubleshooting of analytical technical challenges during ad hoc investigations and process development. Conduct Impurity Mapping, the Fate of Impurities and PARs investigations in collaboration with the chemistry group by generating, collecting and interpreting analytical data whilst adhering to current regulatory requirements (quality by design, GMP, ICH’s guidelines) for API. Contribute to regulatory submissions and patents as required. Communicate regularly with the clients, providing updates on projects progress, hosting client visits, addressing technical queries and delivering client project requirements to the defined timelines. Develop / Expand scientific, technical knowledge by reading the peer reviewed scientific literature, attending scientific conferences and relevant training. Ensure that the site’s technical, quality and safety metrics are maintained.Education and Qualifications:
Relevant qualification such as BSc, masters or PhD in relevant scientific discipline with a significant experience (min. 3 years) in industry or academia. Experience in analytical method development, characterization and validation would be desirable. The candidate should have experience in the following: HPLC, UHPLC, GC, LC/MS, GC/Headspace, GC/MS, UV, IR, KF, ion chromatography, ICP.Knowledge, Skills, Abilities:
Demonstrated ability to think critically and innovatively combined with a willingness to learn and to overcome challenges. The candidate should have good organizational skills and a proven troubleshooting ability, and an ability to respond to technical challenges within agreed timelines. Embrace and participate in PPI (Practical Process Improvement) initiatives to help identify improvements and cost savings to the business. Excellent technical writing and communication skills with the ability to work in cross functional teams. Knowledge and experience of the pharmaceutical industry with an understanding of the chemistry development process. Demonstrated core laboratory skills and expertise in various wet chemistry and analytical techniques such as spectroscopy and chromatography techniques.-
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