Senior Scientist, Immunoassay Bioanalysis

Come Join Our Growing Team!

We are seeking a motivated, skilled Senior Bioanalytical Scientist in support of our Immunoassay Bioanalysis Laboratory in Germantown, MD. This role will lead development and validation of immunoassays, cell-based assays, qPCR, and/or flow cytometry as required, to detect/monitor biologics in clinical and preclinical analysis.

What The Job Entails:

• Participates in performance of lab-specific assay development, validation and sample analysis
• Prepares data tables and reports within Laboratory Information Management Systems (Watson™)
• Provides support in obtaining reference materials, control plasma and project-specific consumables to meet the objectives of the study
• Participates in data transfers, pre-clinical and clinical data management tasks
• Assists in training personnel in the operation, maintenance, and troubleshooting of laboratory equipment
• Contributes to department initiatives, e.g. process improvements, as required
• Always complies with the Laboratory Safety Policy
• 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, qPCR, and/or flow cytometry as required, to detect/monitor biologics in clinical and preclinical analysis
• Highly experienced with performance of PK/PD, ADA and biomarker immunoassays

Requirements:

• Bachelor's Degree or higher degree, in a scientific related discipline
• Minimum of 7 years relative work experience
• Exceptional analytical and problem-solving capabilities
• Full understanding of regulatory requirements of study types assigned
• Excellent written and verbal communication skills in a team environment