Scientist III, Analytical R/D

Essential Functions

• Develop and validate analytical methods to support formulation drug development under minimal supervision
• Perform routine testing including stability testing, solubility studies, and Drug-Excipient Compatibility studies as and when needed
• Ability to own projects independently including literature review, material sourcing, design experiments, executing/delegating tasks and providing data to customers
• Perform forced degradation studies
• Author product development reports and investigation reports
• Author/Co-author analytical methods, validation and transfer protocols, instrument qualification protocols, validation/qualification reports, SOPs, etc.
• Execute routine instrument troubleshooting, peer review of laboratory notebooks, maintenance of logbooks
• Maintain laboratory equipment, including calibration scheduling, acquisition, and basic maintenance programs
• Maintain a GMP-compliant analytical laboratory and safe working environment, maintain lab inventory
• Review laboratory notebooks, data packs, and reports under minimal supervision. Trend stability data.
• Present data to the customers, attend client meetings as needed under minimal guidance
• Supervise, mentor, train and develop junior scientists

Supervisory Responsibilities

• No direct reports
• Indirect reports: Yes

Key Relationships

• Process Development/ Formulation R&D
• Quality Control
• Quality Assurance

Physical Demands and Work Environment

• Occasionally required to lift/carry up to 20lbs
• Requires standing/walking for extended periods in a climate-controlled lab environment
• Frequent bending, lifting, pushing, pulling, carrying, and sitting may be required
• May be exposed to moderate noise levels in a climate-controlled lab environment