Scientist – Analytical (Temporary)
The Analytical Development Scientist will, under supervisor, be responsible for development and execution of analytical test methods that facilitate drug substance and drug product development / manufacturing and regulatory submissions for clinical study introduction through phase 3 trials. Activities includes test method development, qualification/validation, transfer and execution. This position is also called on to support late stage troubleshooting and development of products, processes, and methods in support of product commercialization.
Develop and execute chemical and instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR ) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials. Accurately follow established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making. With supervision, plan and execute in-house stability studies for drug substance’s, intermediates, and prototype drug products with supervision and as appropriate, assist / lead the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results.
BS in chemistry or closely related field; 7 years relevant industrial experience in an R&D/QC setting (MS with 2-4 years) Proficient using MS-Excel, MS-Word as well as data systems for computer controlled instrumentation
Significant practical experience conducting HPLC analysis and troubleshooting.
Significant experience evaluating analytical data and drawing meaningful conclusions
Knowledge of cGMP expectations for laboratory records and quality systems; Strong attention to detail, excellent written and oral communication skills; Ability to provide ideas for process improvements; Ability to work with a team of individuals to meet goals; Experience working in a timeline driven setting.