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 (DSP)
Builds
Drug Substance (DSP) manufacturing batches
Domain
Biopharmaceuticals / cGMP Manufacturing
Required skills
Chromatography, Virus inactivation, Virus filtration, Ultrafiltration-diafiltration, Batch record review, Equipment maintenance, Troubleshooting, SOP authoring, Deviation investigation, CAPA, Change control, Data integrity, Lean initiatives, Technology transfer
Preferred skills
Pharmaceutical industry experience, Science or engineering-based tertiary education
Technologies
Chromatography systems, Filtration systems, Ultrafiltration/Diafiltration systems, Fill systems
Responsibilities
Execute DSP unit operations including chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration, and drug substance final fill; Follow production schedules, batch records, and SOPs in a cleanroom cGMP environment; Monitor processes and identify operational or technical issues during execution; Maintain production suites, equipment, and supplies to ensure operational readiness; Complete logbooks, batch documentation, and ensure accurate data recording; Perform batch record review, closure, and material reconciliation; Conduct routine equipment maintenance, calibration checks, and functional testing; Troubleshoot equipment and process issues within scope of role; Author, revise, and maintain SOPs, logbooks, and controlled documents; Participate in deviation investigations and root cause analysis; Complete corrective and preventive actions (CAPA) in a timely manner; Support closure of deviations and change controls; Participate in lean (Operational Excellence) initiatives and continuous improvement activities; Assist in technology transfer activities and adoption of new DSP processes; Communicate with suppliers/vendors to resolve technical issues; Ensure compliant execution of DSP manufacturing activities under cGMP conditions; Maintain high standards of data integrity, documentation accuracy, and traceability; Take ownership of production area readiness including equipment, materials, and documentation; Proactively identify, communicate, and help resolve operational issues; Ensure equipment is maintained, functional, and fit for purpose; Contribute to continuous improvement and operational efficiency initiatives; Support implementation and understanding of new technologies within DSP; Adhere to Thermo Fisher Scientific cGMP Quality Management System requirements; Comply with Environmental Health & Safety (EH&S) policies and procedures; Support quality systems including deviations, CAPA, and change control processes; Maintain effective communication with internal stakeholders and external suppliers
