Principal Scientist- Immunoassay | Germantown, MD

Detailed Information

  • Location: Germantown, MD

  • Company: Pharmaron

soluble protein biomarkers in support of biologic drug development in a GLP environment or similar Highly experienced in flow cytometry including at least 7 color assay development and validation Experienced in cell-based assays including Neutralizing Antibody Assays (Nab) An expert in a GLP environment and all regulatory aspects associated with immunoassays used in biologic drug development Experienced in the use of LIMS/Watson including data downloads for reporting.

Experienced in immunoassay platforms that include three of the following: MSD, ELISA, Luminex, Gyros, Quanterix, Ella Will act as a representative of Pharmaron at scientific conferences and at customer sites Will represent

Pharmaron in professional organizations like AAPS, SOT or ASGCT and may lead subcommittees that publish industry recommendations. Assists in training personnel in the operation, maintenance, and troubleshooting of laboratory equipment Always complies with company Standard Operating Procedures unless specifically varied in the validation or sample analysis plan.

May perform study director/PI activities such as: Controls appropriate bioanalytical portion of studies by designing the experimental approach, overseeing the experimental execution, collating and interpreting scientific data and generating study reports, working in close co-operation with study Sponsors at all stages. Carries

out laboratory tasks, working with other laboratory staff to progress study-specific experimental work and, as necessary, to support non-study-specific laboratory duties.

Prepares or reviews standard operating procedures for use by the Company, as required. Provides scientific and technical support to colleagues in the Business Development group, as required. This may involve participation in client visits, both inbound and outbound. Contributes to the training, monitoring and mentoring of staff as necessary. Assists with scientific investigations and efforts to troubleshoot/solve assay problems. Attends and presents at Scientific Conferences. Lead development and validation of Immunoassays, cell-based assays, and/or flow cytometry as required, to detect/monitor biologics in clinical and preclinical studies associated with drug development.

Education & Experience Ph D + at least 8 years relevant immunoassay experience OR Master of Science in relevant field + at least 11 years relevant immunoassay experience OR Bachelor of Science in relevant field + at least 17 years relevant experience. #LI-RA1

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