Analytical Development Chemist

As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics, or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

Analytical Development Chemist

Job Description

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.

Responsibilities:

• 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.

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.

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