Bioanalytical Scientist, Immunoassay Bioanalysis
Pharmaron

Germantown, Maryland

Posted in Pharmaceuticals


This job has expired.

Job Info


Come Join Our Growing Team!

We are looking for a Bioanalytical Scientist to support our Immunoassay Bioanalysis Laboratory on a full-time basis in our Germantown, MD facility.

This position is responsible for conducting research dealing with the understanding of human diseases and the improvement of human health and engaging in clinical investigation, research and development, or other related activities.

Essential Functions

  • Participates in performance of lab-specific assay development, validation and sample analysis.
  • Prepares data tables and reports within Laboratory Information Management Systems (Watson™, Debra™ and/or Stacy™)
  • 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
  • May contribute 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.
  • Provides support in developing and validating Immunoassays and cell-based assays, qPCR, and/or flow cytometry as required, to detect/monitor biologics in clinical and preclinical analysis.
  • Experience with performance of PK/PD, ADA and biomarker immunoassays.

May perform study director activities such as:
  • Controls 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 Sponsor's 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.

Competency (knowledge, skills, and abilities)
  • Good Laboratory Practice (GLP) regulations (21 CFR part 11 and 58)
  • Good Clinical Practice (GCP) regulations
  • International Conference on Harmonisation (ICH) guidelines
  • Critical Thinking - Using logic and reasoning to evaluate alternative solutions, conclusions or approaches to problems.
  • Complex Problem Solving - Identifying readily identifiable and clearly-defined problems and reviewing related information to develop and evaluate options for solutions.
  • Time Management - Managing one's own time and being considerate of the time of others.
Required Education, Knowledge and Experience
  • Master of Science in relevant field + at least 2 years relevant experience, OR Bachelor of Science in relevant field + at least 4 years relevant experience.
Preferred Education and Experience
  • Hands-on experience with liquid handler (Hamilton, Tomtec) and Watson LIMS is preferred.
  • The ideal candidate will have relevant experience in qPCR, and/or flow cytometry.


This job has expired.

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