The Expert Scientist is responsible for the cell-based characterization assays for commercial protein drugs, working in the Rockville MSAT analytical team. In addition, the Scientist participates in non cell-based characterization and in-process analytical testing including ELISA and residual DNA.
The role is responsible to transfer-in characterization methods from Research & Development / Clinical departments to implement, execute, and analyze them for comparability studies and analytical investigations. Cell-based methods are carried out in a BSL2 and GMP environment. The role leads troubleshooting root cause analysis for issues arising in MSAT or other departments.
To achieve your objectives, you will work closely with the QC Bioassay and R&D departments. For the MSAT analytical department, this will be an expansion of scope and the team will rely on your subject matter expertise . Accountability:
Key accountabilities of the role are:
- Serve as a project lead for DS and DP cell-based characterization assays within MSAT: Method transfer and execution
- Primary contact and subject matter expert for cell-based bioassays in MSAT
- Strong working relationship with QC Bioassay leadership and personnel
- Represent MSAT Analytical group in matters of cell-based assays in meetings and documentations
- Working in a GMP and BSL2 environment
- Adhere to documentation rules when working with GMP equipment
- Be able to work independently without direct supervision
- Flexibility to learn/execute non-bioassays, primarily process residuals
- Strong oral and written communication skills
Documented experience with the development and execution of reporter-based assays using luciferase or other similar systems to measure the response in cell systems Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- BS with a minimum of 8 years, MS with a minimum of 6 years, or PhD with a minimum of 2 years industry experience
- Experience in GMP environment
If you have the following characteristics, it would be a plus:
- Understanding of the mechanism of antibody drugs
- Experience in method troubleshooting
- Experience in method development, qualification, or validation.
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