Senior Scientist - Analytical Development

Job description:

- Support qualification and validation of analytical methods for biologic drugs and process impurities

- Perform experiments for ELISA, potency assays, qPCR, and other molecular biology assays

- Conduct analytical method development, qualification, and validation under cGMP

- Apply molecular biology, cell biology, and immunochemistry expertise across method lifecycles

- Support technology transfer of analytical methods into QC labs

- Write and revise SOPs, reports, protocols, and related documentation

- Coordinate with other labs to prepare methods for transfer to QC GMP labs

- Provide training and technical guidance as needed

- Utilize Spectramax plate readers and SoftMax GMP software

- Contribute expertise in biologics characterization and analytical testing

- Leverage knowledge of quality requirements, lab safety, and biologics processes

- Experience with biophysical characterization (CE, chromatography, SEC/RP/IEX-U(H)PLC, SDS-CGE, iCIEF, CIEX, peptide mapping) is a plus

Job Type: Contract

Pay: $50.00 - $70.00 per hour

Expected hours: 40 per week

Benefits:

- Health insurance

Experience:

- ELISA: 5 years (Required)

- qPCR: 5 years (Required)

- Assays: 5 years (Required)

- Analytical Development: 3 years (Required)

- chromatography: 1 year (Required)

- Molecular biology: 1 year (Preferred)

- Spectramax / SoftMax / Plate readers: 1 year (Required)

Work Location: On the road