Columbia, Missouri, United States
Designs and conducts simple and complex routine and non-routine experiments and appropriate procedures independently using laboratory equipment (balances, pipets, meters, LSC, chromatographs, etc.), computer resources, and institutional libraries in accordance with applicable GLP regulatory (e.g., EPA, FDA, OECD, etc.) requirements as defined by protocol, method, and standard operating procedures (SOPs). Routinely develops and utilizes equipment, formulas, processes, and methods to solve technical issues. Performs complex data analysis and first level, peer, and scientific review of this data for accuracy and completeness and prepares data and reports for primarily Product Chemistry studies ensuring auditable quality. Serves as an expert for technical issues for staff and external customers. Trains, monitors, and directs staff on techniques necessary to perform laboratory assignments. Adheres to schedule according to the laboratory’s or contracting organization's timetable and establishes daily or weekly routines necessary to ensure on-time delivery. Trained in the proper handling of regulated materials according to company procedures and regulatory requirements. Responsible for ensuring smooth communication, collaboration, and completion of studies in a timely manner. Delegates and coordinates services for the group. Promotes a positive environment to facilitate change and teamwork. Provides a teaching and coaching role, and serves as a role model for adherence to established standards and GLP regulations. Able to take charge of the bigger picture and prioritize work and resources depending on need, and have the flexibility to navigate unexpected scenarios. Works collaboratively with program management, business development, and senior management.
Assists in the planning and conducts somewhat complex routine experiments and appropriate procedures with minimal supervision using laboratory equipment (e.g., balances, pipets, meters, HPLC, etc.), computer resources, and institutional libraries in accordance with applicable GLP regulatory (e.g., EPA, FDA, OECD, etc.) requirements as defined by protocol, method, and standard operating procedures (SOPs). Performs analysis, first level, and peer review of data for accuracy and completeness and prepares data and reports for primarily Product Chemistry studies ensuring auditable quality. Assists in the training of staff on techniques necessary to perform laboratory assignments. Adheres to schedule according to laboratory's or contracting organization's timetable and establishes daily or weekly routines necessary to ensure on-time delivery. Trained in the proper handling of regulated materials, potential biohazard materials, and toxic chemicals according to company procedures and regulatory requirements. Along with the responsibilities listed above for Associate Scientist II, assists and/or serves as study director for GLP studies performed in Product Chemistry.
Performed and documented all manufacturing steps and verifications as described in the company procedures/polices. Media production was completed in a timely manner according to the production schedule. Setup and checks to ensure filters were used accordingly. Labeled all media and verified all media was stored based on all regulatory and Master Formulary specifications. Operation of proper equipment and clean in place procedures. Calibration of instruments, scales, and pH meters. Performed media dispense setup by setting the pump dispense volume, placing the dispense head and verifying connections and bag numbering to avoid switched well. Followed proper documentation review for Device History Record-Master Formulary. Cleaned and organized lab workspace.