Position Summary
The Scientist position within Analytical Development performs small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization.
They develop new methods using chromatographic, characterization, and wet chemistry techniques to enable small molecule drug substance and drug product development throughout various stages of drug development.
They will primarily perform internal laboratory work and interact with external partners for method development, validation, and analytical testing.
The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs.
- Develop, validate, and transfer methods for analysis of drug substance and drug product
- Perform independent hands-on experimental work using various chromatographic and spectroscopic techniques, KF, dissolution and physical characterization techniques such as X-ray powder diffraction, DSC, and TGA
- Perform data analysis and interpretation
- Generate technical documents (eg, reports, lab notebooks, procedures) and technical presentations
- Present data to key stakeholders and management
- Troubleshoot technical problems for molecules in Discovery Research and drug development
- Evaluate new technologies for Alkermes
- Perform peer review of colleague’s electronic notebooks
- Perform other duties as assigned
- PhD (0-3 years) or MS (>
5 years) with related experience in analytical chemistry, organic chemistry, or biochemistry
- Experience with advanced analytical techniques (HPLC / UHPLC, LC / MS, GC, Dissolution, FTIR, UV / Vis, KF, X-ray powder diffraction, DSC, TGA,
- Strong instrumental background, familiarity with operation and troubleshooting of LC instrumentation / software (Waters, Agilent, Gilson, etc)
- Knowledge of pharmaceutical sciences
- Familiarity with statistical analysis for analytical chemistry, including experimental design (DoE)
- Understanding of cGMPs, ICH guidelines, and compendial requirements
- Good oral and written communications
- Ability to prioritize tasks and responsibilities for work assignments to meet project timelines
LI-MB1
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