Analytical Development Chemist

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
The Analytical Development Chemist will function as a key member of the Process Development Service Team. You’ll be responsible for providing analytical expertise and technical support for all phases of drug development. This will include supporting the analytical aspects of route scouting, route development, proof of concept of new and existing manufacturing routes for APIs. You will focus on the development of new or existing analytical methods and their subsequent validation/qualification and transfer to the clients. You’ll be able to work as part of a team, across functions and on your own initiative and be able to review current practices with the target of using Practical Process Improvements (PPI) to identify improvements and cost saving to the business.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• Relevant qualification such as BSc; masters or PhD in relevant scientific discipline with a significant experience in industry or academia.
• Experience in analytical method development, characterization and validation.
• A subject matter expert with HPLC, UHPLC, GC, LC/MS, GC/Headspace, GC/MS, UV, IR, KF, ion chromatography, ICP.
• Demonstrated ability to think critically and innovatively combined with willingness to challenge.
• The candidate will have great organizational skills and proven ability of troubleshooting to rapidly respond to technical challenges. Embrace and participate in PPI (Practical Process Improvement) initiatives to identify improvements and cost saving to the business.
• Excellent technical writing skills and oral communication with the ability to work with cross functional teams with collaborative communication skills to engage with employees and clients at all levels.
• Knowledge and experience within a pharmaceutical manufacturing and chemical development environment and an understanding of the drug development process is desirable.
• Demonstrated core laboratory skills and expertise in various wet chemistry and analytical techniques such as spectroscopy and chromatography techniques, with an excellent understanding of the relevance of the data generated.
  At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer

• Provide technical expertise and analytical support for the introduction of new products to the Cork site, including method development, validation/qualification and transfer of methods to clients as required.
• Lead in troubleshooting analytical technical challenges during the development, pre-validation validation/qualification and transfer of methods.
• Plan, execute and evaluate fate of impurities studies in collaboration with colleagues and client through interpretation of analytical data and adhering to current and emerging regulatory strategies (quality by design, GMP, ICH’s guidelines) for API.
• Complete analytical data collection, interpretation and characterization of compounds while ensuring proper documentation of experimental data is adhered to.
• Support innovative development of new analytical methods as well as improvement and optimization of current methods.
• Provide lead analytical support to development projects in the laboratory by supporting route scouting, route development, proof of concept and process proven acceptable range studies.
• Author or contribute to regulatory submissions and patents as required.
• Communicate regularly with the clients, providing updates on projects progress, hosting clients 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 via relevant training.
• Ensure the delivery of projects in the required timeframe and ensure that the site’s technical, quality and safety metrics are all achieved.