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 per regulatory guidelines.

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
• Knowledge of leading validation and sample analysis with PK and Immunogenicity assays
• 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
  
  
  

Compensation within the posted range is determined by a candidate's education level and/or years of experience in the field.


About Pharmaron

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.