Job Description

• Responsible for conducting routine and non-routine analysis of raw materials, In-Process and finished formulations according to standard operating procedures.
• Compiles data for documentation of test procedures and prepares reports.
• Calibrates and maintains lab equipment.
• Reviews data obtained for compliance to specifications and reports abnormalities.
• Revises and updates standard operating procedures as needed. Supports product development as needed.
• Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.
• Works on problems of moderate scope where analysis of situation or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Normally receives general instructions on routine work and detailed instructions on new assignments. Supports QC release and stability testing.
• Assists in performing various analyses, such as HPLC, UV-Vis spectroscopy, particle size determination, moisture analysis and general wet chemistry techniques.
• Maintains accurate and well-organized laboratory records and worksheets. Executes on assigned tasks following SOPs and GMPs.
• Performs other duties as assigned.      

• A minimum of a Bachelor’s degree in a scientific discipline is required. Equivalent experience may be accepted.
• A minimum of 2 year related experience (which can include lab experience while in school) is preferred. 
• Must have a demonstrated working knowledge of scientific principles.
• Practical experience in HPLC, UV/Vis spectroscopy, and/or moisture analysis is a plus.
• Good oral and written communication skills are required.
• Some experience in data analysis is preferred. Knowledge of FDA regulations and cGMPs for drugs and/or device are a plus.
• Aerosol and pulmonary delivery experience is a plus.
• Must be well organized and willing to work as part of a team.
• Must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function.  
• May be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents.
• Must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self contained breathing apparatus) for certain tasks essential to the job function.
• Must be able to maneuver themselves under 30 inch clearances.
• Must be able to able to accurately detect color and have 20/20 vision (with/without corrective lenses).
• May be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function. 

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