Description

The Principal Scientist I will provide technical support for multiple project teams. This individual will evaluate and interpret analytical results, develop, validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks.

• Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
• Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
• Perform analytical chemistry assays based on new and existing methodologies
• Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
• Write technical reports to document analytical methods
• Maintain laboratory notebooks documenting work
• Maintain compliance with GMP SOPs and DEA regulations
• Transfer documented analytical methods to the QC and Process Support Group departments
• Set up new or existing analytical methods for compound identification, purity and potency testing.
• Coordinate off-site testing as necessary
• Conduct testing of analytical samples for the Chemical Development Department as needed.
• Qualify reference materials.
• May also perform other duties as required.

Ph.D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 12 years of experience in lab environment, pharmaceutical experience preferred.

Demonstrated ability to transfer processes to commercial scale manufacturing.  

Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.

PI280624902