DSP Bioprocess Scientist
Core
Execute DSP unit operations including chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration, and drug substance final fill in accordance with approved protocols in a cleanroom cGMP environment.
Role type
Bioprocess Scientist (Drug Substance Production)
Builds
Drug Substance (DSP) batches for pharmaceutical customers
Domain
Biopharmaceutical manufacturing / cGMP
Required skills
chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration, cGMP compliance, batch record review, equipment maintenance, troubleshooting, deviation investigation, CAPA, change control, data integrity
Preferred skills
lean operational excellence, technology transfer, continuous improvement
Technologies
chromatography systems, filtration systems, ultrafiltration-diafiltration systems, cleanroom equipment
Responsibilities
Execute DSP unit operations including chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration, and drug substance final fill; Monitor processes and identify operational or technical issues during execution; Troubleshoot equipment and process issues within scope of role; Participate in deviation investigations and root cause analysis; Conduct routine equipment maintenance, calibration checks, and functional testing; Author, revise, and maintain SOPs, logbooks, and controlled documents.
Seniority
Mid-level IC
