Process Development Associate, Analytical Method Development
Current
Gaithersburg, Maryland, United States
- Executes and analyzes data from ELISAs and PicoGreen assays to assess physical titer, residual host cell proteins, and dsDNA in support of lentiviral vector (LVV) production, applying strong analytical skills to ensure.
- Cultures and maintains mammalian cell lines in a BS-II laboratory, employing aseptic technique and Good Laboratory Practice (GLP) protocols to ensure cell health and experiment reliability.
- Troubleshoots and supports the transfer of assays to GxP environments, ensuring compliance with Good Manufacturing Practice (GMP) standards, and actively assists in onboarding new analytical methods to meet client.
- Authors and reviews Standard Operating Procedures (SOPs), protocols, and reports related to method transfer activities, ensuring that all documentation follows Good Laboratory Practices (GLP) and Good Manufacturing.
- Maintains detailed and accurate lab notebooks, supporting robust documentation practices for traceability and reproducibility, while leading 5S initiatives to optimize laboratory organization and resource utilization.
- Designs and implements streamlined data analysis tools using VBA in Excel, enhancing the efficiency of routine sample testing for the Process Development team and facilitating issue resolution and method optimization.