Bioassay Scientist - Method Development
About The Position
Perform testing to support analytical development, manufacturing process development, and process validations. Accurately record data in a timely manner, including maintenance of detailed records in compliance with applicable Good Manufacturing Practice (GMP), safety, and environmental requirements. Ensure data integrity and protocol compliance. Troubleshoot, and execute experiments independently. Analyze data, interpret results, and report data in laboratory notebooks. Collaborate with client to troubleshoot assay problems as they occur. Support regulatory filings, including INDs and BLAs. Provide technical support (ELISA, FRETS, Cell based assays, Flow cytometry & other techniques) with development and QC laboratories and support Quality Assurance. Ability to handle and maintain various cell lines following aseptic techniques in GMP labs.
Requirements
- At least a completed BS/MS in Chemical Engineering, Biological Sciences, Chemistry or Biochemistry
- Approximately 3 years of relevant experience
- Experience with PCR
- Experience with cell-based assays
- Experience with FRET
- Experience with MSD content assays
- Experience with Gel Electrophoresis
- Experience with Western Blot
- Authorization to work in the United States indefinitely without restriction or sponsorship
Nice To Haves
- Familiarity with LIMS
- Knowledge of statistics
Responsibilities
- Perform testing to support analytical development, manufacturing process development, process validations.
- Accurately record data in a timely manner, including maintenance of detailed records in compliance with applicable Good Manufacturing Practice (GMP), safety, and environmental requirements.
- Ensure data integrity and protocol compliance.
- Troubleshoot, and execute experiments independently.
- Analyze data, interpret results, and report data in laboratory notebooks.
- Collaborate with client to troubleshoot assay problems as they occur.
- Support regulatory filings, including INDs and BLAs.
- Provide technical support (ELISA, FRETS, Cell based assays, Flow cytometry & other techniques) with development and QC laboratories and support Quality Assurance.
- Handle and maintain various cell lines following aseptic techniques in GMP labs.
Benefits
- Comprehensive medical coverage
- Dental options
- Vision options
- Life insurance
- Disability insurance
- 401(k) with company match
- Paid vacation
- Paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
