An amazing opportunity has arisen for a Scientist Analytical R&D to join our Biologics Analytical R&D Science & Technology Team - Development Laborator at our R&D facility in Dunboyne. The Specialist is a scientific role tasked to collaborate closely with the Process Science Team within Development Laboratory providing non-GxP analytical support for technology transfer, investigational and operational support work taking place in the Development Laboratory. In addition to benchtop analytics, the scope of the team also includes support for PAT and technology innovation.
We are looking for a team player with strong scientific skills and ability and passion for science, technology and innovation in a laboratory setting. Applicants must have effective organizational and multi-tasking skills, have demonstrated scientific excellence, and have superior communications skills, both written and oral. A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected.
What you will do:
Bring energy, knowledge, innovation to carry out the following:
* Execution of analytical testing of drug substance and process intermediates from scale down models and manufacturing scale
* Execution of analytical method qualifications and method transfers
* Documentation of results in the form of technical protocols and reports, authoring analytical methods, SOPs and other documents as required
* Troubleshoot methods to ensure seamless method qualification & execution in the laboratory
* Support equipment maintenance, calibration and qualification & periodic review
* Cross-train scientists within the department for new and existing technologies.
In order to excel in this role:
What skills you will need
* A minimum of 3 years of experience working in a relevant academic or industry field.
* Experience in Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization techniques.
* Demonstrated initiative and creativity for developing innovative solutions to complex problems.
* Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
* Ability to work in less structured problem-solving situations within a work group.
* Ability to explain information and persuade others Understand and apply regulatory/compliance/scientific requirements relative to the role.
* Demonstrate cross-functional collaboration and interaction with multiple stakeholders.
* Experience in antibody biochemistry and the analysis of biologics. Experience with applicable techniques, antibody binding assays, PCR and/or functional cell-based assays is desirable.
* Knowledge of PAT, Data Science and laboratory automation (robotic liquid handlers).
* Background in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DOE) principles as well as data analysis and statistics.
* Knowledge of GMP policies and procedures.
* Analyse and optimise current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies to ensure continued & optimal team performance.
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