Performs routine analytical testing including complex methods such as ELISA, Bioassays, and Cell Culture as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality, for in-process, product release, and stability samples on a daily basis in accordance with all protocols and procedures.
Enters data into Laboratory Information Management System (LIMS).
Perform cell culture for both adherent and suspension cells and independently plate/monitor and set up bioassays as needed.
Performs peer review of test data generated by other analysts to identify discrepancies and out of range results and to ensure adherence to standard operating procedures and GMPs.
Identifies analytical data trends and reports findings and provides recommendations to supervisors for review and consideration.
Conducts investigation when there are out of specification results from testing and reports to supervisor.
Initiates and monitors progress of analytical related Quality event records (e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution.
Develops, revises, and updates standard operating procedures, as needed.
Collaborates with Development (Analytical Sciences) team members to participate in the development, transfer, and validation of analytical testing methods and conducts training on analytical test methods to other QC Analysts as needed.
Collaborates with partners and CDMOs for tech transfer and method validation as needed.
Oversees lab equipment calibration and maintenance processes as required for testing per standard operating procedures, and raises any concerns about equipment to the supervisor for resolution.
Participates in troubleshooting of analytical test methods and instruments, as needed.
Performs special projects related to problems encountered with analytical testing and instruments, and makes recommendations for solutions that will minimize future issues.
Mentors and trains lower lever analysts, as needed.
Authors Reports, protocols as well as memos for validation, critical reagents etc.
Keeps track of Critical Reagent inventory and current expiration dates
Keeps track of failed samples, performs data reviews of failed samples as needed, helps review protocols, reports, create templates/overlays, creates SoftMax Templates and reviews SoftMax Templates.
Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.
Orders reagents as needed.
Experience:
Bachelor's Degree/ Masters in a scientific discipline and minimum of 4 years experience in GMP environment
Experience in one or more of the following areas required: ELISA, Bioassays, Potency testing, Residuals, Quality Control, Raw Material testing, and/or GMP testing.