Associate Scientist, Analytical Operations

Specific Responsibilities & Skills for the Position:

• Independently develops analytical methods for small molecule parenteral/ injectable drug products (purity/impurity by LC, particulate matter, sterility, resuspendability, etc)
• Performs physical characterization of drug substances for parenteral drug products (thermal analysis, particle size, microscopy, XRPD, etc)
• Independently plans and executes experiments
• Develops subject matter expertise in an analytical technique and begins to act as a resource for other employees within the department
• May lead a specific development project or study in support of overall project with supervision
• Independently troubleshoots instrumentation or test methods
• Identifies and investigates root causes for atypical results
• Accurately and timely documents work in laboratory notebooks, logbooks, and laboratory software
• Authors test methods, reports, and other required documentation
• Participates in group meetings and presents results of work; may lead meetings among junior staff
• Proposes next steps in development activities based on interpretation of analytical data
• Analyzes data from multiple sources to draw conclusions on larger project
• Trains others in execution of analytical test methods or analytical techniques
• May support regulatory filings through data acquisition, report writing, and data analysis
• Recommends alternatives, researches new methods and techniques and may proactively seek out senior personnel to discuss potential solutions to problems.
• Manages time independently while adhering to clear deadlines set by manager

Knowledge, Experience & Skills:

• MS degree in Chemistry or Biology with 6+ years of experience
• BA or BS degree in Chemistry or Biology with 8+ years of experience
• Strongest consideration will be given to candidates with demonstrated experience in parenteral drug product development (sterility, device and packaging, particulate matter, etc.)
• Experience with one or more of the following analytical techniques: chromatographic separations (RPLC, SEC, Ion exchange, chiral), mass spectrometry, parenteral characterization (osmolality, subvisible particles, pH, extractable volume, etc), solid state characterization (particle size, XRPD, DSC/TGA, etc)
• Excellent verbal communication and technical writing skills

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