Capable of performing characterization studies for inhalation products, particularly for metered dose inhalers (MDIs). Experienced in developing, validating, and executing test methods for the characterization of MDIs. Should be able to write SOPs, test methods, method validation protocols and reports as per FDA and ICH guidelines and should follow cGMP. Excellent oral and written communication skills and able to thrive in a team environment.
Will perform inhalation testing for inhalation products, particularly MDIs. Will be proficient in MDI characterization methods including total can assay, aerodynamic particle size by cascade impaction, delivered dose through container life, Karl Fischer, spray pattern & plume geometry, foreign particulate matter, and microscopic evaluation. Will work with analytical scientists to support their development of assay and impurities methods and for routine testing. Capable of troubleshooting methods. Prepares SOPs, protocols, and reports. Meets timelines. Performs studies according to the stage-appropriate quality system.
- Proficient in developing, validating, and executing MDI characterization methods
- Must be able to perform laboratories duties that require standing for up to 90% of the work day, lifting containers containing 4+L of liquids and fine motor skills for conducting laboratory experiments (including weighing and pipetting).
- Troubleshoots equipment and coordinates equipment qualification and calibration.
- Maintains a clean and safe working environment. May assist in MDI formulation and filling.
- At least one year of experience in MDI product development
- Perform other duties as assigned.
- BS in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific field with 6+ years’ experience or MS with 4+ years’ experience
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