Associate Scientist, Analytical Development

The Associate Scientist, Analytical Development (AD) is a key contributor responsible for supporting the development and qualification of robust, fit-for-purpose analytical methods for Quality Control (QC).

The Associate Scientist will provide analytical support and document all activities in laboratory notebooks and technical reports following Good Documentation Practices (GDP).

Additional responsibilities include solution preparation, inventory tracking and ordering, and maintaining a clean and orderly laboratory environment.

• Method Development & Optimization (30%): Under the guidance of AD management and scientists, execute experimental protocols for developing and optimizing novel analytical methods (e.g., HPLC, UPLC, CE-SDS, cIEF, UV/Vis, ELISA) for testing drug substances and drug products.
• Under the guidance of AD management and scientists, execute experimental protocols for developing and optimizing novel analytical methods (e.g., HPLC, UPLC, CE-SDS, cIEF, UV/Vis, ELISA) for testing drug substances and drug products.
• Method Qualification (30%) Under the guidance of AD management and scientists, perform hands-on execution of qualification studies, including accuracy, precision, linearity, range, specificity, detection limit, and quantitation limit assessments.
• Under the guidance of AD management and scientists, perform hands-on execution of qualification studies, including accuracy, precision, linearity, range, specificity, detection limit, and quantitation limit assessments.
• Documentation & Compliance (20%) Assist in authoring GxP-compliant technical reports and Standard Operating Procedures (SOPs). Maintain meticulous laboratory notebooks and electronic records and submit for review in a timely manner.
• Assist in authoring GxP-compliant technical reports and Standard Operating Procedures (SOPs).
• Maintain meticulous laboratory notebooks and electronic records and submit for review in a timely manner.
• Additional (20%) Order and receive reagents and labware, as needed. Maintain general and assay-specific inventory. Log and store all received samples and items. Track tasks, meetings, events, etc. in AD team weekly schedule and keep up to date. Fully operate all laboratory equipment necessary to complete responsibilities. Log all equipment usage in necessary locations. Coordinate with other groups for testing/equipment needs. Assist with the day-to-day maintenance of an orderly analytical laboratory. Perform a weekly laboratory walk-through: Update inventory list(s). Dispose of hazardous waste (bench tops, large bins, HPLC waste). Dispose of expired materials (wet and dry reagents). Wash/put away glassware. Clean/organize bench tops. Discard/create waste streams. Seek opportunities for personal and professional growth (conferences, webinars, trainings, etc.).