Novel Labs
Job Description:
Performs laboratory activities including development and validation of chromatographic (HPLC, UPLC, GC) and other applicable analytical methods specific to Metered Dose Inhaler product.
Responsibilities:
• Conduct reverse engineering, pre-formulation and formulation development studies for MDI products.
• Perform release and stability testing of registration and clinical batches.
• Set up and operate laboratory equipment, conduct instrument and analytical method, troubleshooting with supervision.
• Prepare and maintain accurate records in lab notebooks of all testing performed.
• Follow protocols, methods, standard operation procedures.
• With supervision, develop, optimize and validate chemical analytical methods using HPLC, UPLC, GC and Karl Fischer.
• With training, develop, optimize and validate specialized physical test methods for MDI products such spray and plume pattern characterization, aerodynamic particle size (APSD) and dose content uniformity (DUSA).
• With supervision, investigate deviations, out-of-specification and out-of-trend results.
• Prepare standards and specifications in compliance with cGMP/GLP regulations.
• Conduct lab work in accordance with SOPs; assure compliance to Quality procedures and follow safety rules and procedures. Comply with all Corporate guidelines and policies.
Job Qualifications:
Master’s Degree in Chemistry or related discipline (e.g., Pharmaceutics, Pharmaceutical Manufacturing, Industrial Pharmacy). As alternative, Bachelor’s Degree in Chemistry or related discipline with extensive laboratory experience. Require skills in liquid chromatography (HPLC, UPLC) and gas chromatography (GC). Experience in analytical method development and validation preferred.
Job Location:
Somerset, NJ.
Submit resume referencing job title “Analyst, Support Metered Dose Inhaler Product Development” to HR, Novel Laboratories, Inc., 400 Campus Drive, Somerset, NJ 08873.
Please send your resume to hr@novellabs.net
