Expert Separation Scientist
• Bachelors Degree in Chemistry or closely related science with minimum of 10 years relevant experience.
• Deep understanding of separation science (HPLC/UHPLC) and extensive experience with troubleshooting chromatographic analyses is essential.
• Experience representing analytical aspects in project teams during clinical phase development – understanding of analytical project lifecycle
• Demonstrated ability to work in GMP compliant environment
• Analytical experience developing small molecules in a GMP drug development organization
• Experience in key analytical aspects of product development – LC method development, method validation, batch release and stability testing, authoring methods, specifications, sections of regulatory submissions, data trending, OOS/Atypical investigations
• Demonstrated expertise with HPLC, UV, analytical balances, volumetric dilution, pH, and general analytical techniques
• Command of typical software systems including Empower (or similar chromatographic software), Word, Excel, Powerpoint, etc.
• Demonstrated ability to work in multi-disciplinary team
• Demonstrated ability to represent the analytical department at product development meetings. This requires knowledge of the development process, proactive communication and intervention, regulatory requirements and trends, and ability to develop strategies to progress analytical development
• Demonstrated flexibility in working roles and circumstances
• MS Degree with minimum 5 years relevant experience, or Ph.D.
• Experienced with chemical and physical characterization of topical products. Operation and interpretation of MS or MS/MS a plus.
• Experience with Quality by Design approach to product development
• Proficiency with computer software (learning new software quickly)
• Demonstrated experience in developing and implementing new technologies, ways of working, tools, to improve capability and throughput
• Experience in overseeing outsourced analytical testing – Authoring contracts, method transfers, data review and trending and designing work packages to achieve CMC team objectives.
The Dermatology Therapy Area Unit within GSK is a leading research based team focused on delivering topical formulations of NCE’s to patients. We work in a highly integrated and collaborative environment where sharing ideas and data is a daily experience to ensure rapid learning and progression of our burgeoning topical portfolio.
This opportunity is for an expert in separation sciences (primarily liquid chromatography) to contribute to progressing existing projects through clinical stages, technical transfer, and launch, and to implement new ways of working and new capabilities in dermal product characterization.
You may apply for this position online by selecting the Apply now button.
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