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Analytical Scientist
5 months ago
The role is primarily lab-based, supporting the inhalation product development (IPD) analytical sciences group conducting analytical experiments.
Must have very good understanding of the range of laboratory procedures relating to lab analytical testing and be competent in chromatographic instrument trouble shooting and theory.
Experience testing inhalation products such as pressurized Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs) is preferred.
Responsibilities:
Under general guidance, design experiments and conduct analytical experimental work related to advancing IPD product quality and performance.
Able to identify aberrant data and effectively communicate observations to project management.
Participates in the development of an investigational plan.
Under general guidance, begins to develop project leadership skills.
Effectively document experiments and results in appropriate formats.
Under general guidance, prepare technical reports and/or CoAs to summarize data and document experimental conclusions.
Under general guidance, evaluate data for trends indicative of product performance, method performance, or analyst performance.
Communicate project status and concerns to management.
Preferred:
Experience testing inhalation products preferred, especially MDIs, with a variety of active pharmaceutical ingredients at different stages of development.
University degree (BS or MS) in the field of chemistry, pharmaceutical science, or related field.
MS with 0+ years, BS with 3+ years of pharmaceutical industry experience.
In-depth knowledge in one or more analytical topic areas: HPLC, GC, KF moisture testing, MDI/DPI performance testing.
Experience working in a GMP testing laboratory, and/or familiarity with relevant external guidance documents and cGXPs in support of analytical testing.
Must be able to effectively communicate verbally and through technical writing (documentation of laboratory experiments).
