Scientist III - Analytical Testing - Compendial , Raw Material Testing , GMP

Responsibilities

• Develops analytical methodology for analysis via titrations UV, AA, IR, TOC, UV, and/or particle size.
• Performs GMP review of solutions and wet chemical analyses and chromatography.
• Performs one or more of the following techniques: assays (potencies, related substances), dissolution, moisture content, identification, and various other wet chemistry-based measurements.
• Evaluates and interprets generated data.
• Analyzes information for technical correctness and accuracy.
• Solves problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Writes test procedures, protocols, and reports.
• Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Affords assistance in removal of hazardous waste, routine equipment cleaning, and restocking of consumable products and reagents.
• Effectively uses various laboratory software packages (Empower3, ProCal, Master Control, ELN, etc.).
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Safely handles potent compounds.

Qualifications

• Associate’s degree and 16+ years of related experience.
• Bachelor’s degree and 6+ years of related experience.
• OR Master’s degree with 2+ years of related experience required or PhD with 0+ year of experience.
• Experience in Pharmaceutical, CDMO, or cGMP required.
• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Excellent knowledge of Laboratory equipment and safety required.
• Expert knowledge of Laboratory Documentation is required.
• Working knowledge of cGMP in a pharmaceutical or regulated environment required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.