Job Title : Biological Researcher I
Location : West Chester, PA 19380
Months : 6+ Months
We are seeking a highly motivated individual with experience in cell-based and/or ADA assay development, and sample analysis in support of immunogenicity assessment of protein therapeutics. You will be a member of Specialty Bioanalytics, which plays a critical role in development of biological therapeutics from early stage research, IND enabling GLP studies, clinical trials through BLA submission and post marketing support.
- Participate in Cell-based and/or ADA method development, in support of preclinical and clinical immunogenicity assessment
- Conduct method qualification and sample analysis in a regulated environment, including but not limited to planning assay runs in Watson LIMS, performing the assay, and data summary
- Perform data analysis using Watson LIMS, data transfer, and assist in preparation of assay qualification/validation as well as sample analysis reports
- Maintain laboratory records for compliance/regulatory audits
- Procure, inventory, and track assay reagents
- Help sample inventory in collaboration with sample management team and maintain sample chain of custody records
- B.S. in Immunology, Biology, Biochemistry, or a related field, with 1-3 years of relevant bioanalytical assay (cell-based, ADA, or biomarker) experience in pharmaceutical, biotechnology, and/or CRO industry.
- Preference will be given to candidate with working knowledge of GLP, GCP and regulatory environment.
- Experience with cell-based assays and/or ligand binding assays/ADA method development and execution of immunoassays for immunogenicity assessment is highly preferred.
- Must be proficient in Excel and data processing. Experience with a lab data management system such as Watson LIMS is preferred.
- SoftMax Pro for data analysis and data summary as well as data transfer and report writing is a plus.
- The candidate must be able to work collaboratively in a diverse, fast-paced environment with ability to multi-task. Good communication and interpersonal skills are required.
immunoassays , cell culture, cell based assays, LIMS