Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days
Core
Execute downstream purification operations (column chromatography, TFF, viral filtration/inactivation) and support facility startup/commissioning for bulk drug substance manufacturing.
Role type
Senior Associate Manufacturing (Downstream)
Builds
Bulk drug substance (downstream purified product)
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
physical/clinical work
Required skills
cGMP compliance, aseptic techniques, equipment operation, process monitoring, documentation (EBR), CAPA implementation, cross-functional collaboration
Preferred skills
Biotech/pharma startup experience, downstream purification knowledge, NC BioWorks certification, EBR/MES system proficiency
Technologies
Column chromatography, TFF, Viral filtration, Viral inactivation, EBR, MES, Delta V
Responsibilities
Perform hands-on manufacturing operations and equipment setup/cleaning; Execute process tasks and in-process sampling; Support facility startup, commissioning, and qualification; Initiate and investigate quality observations; Collaborate with QA/QC, Engineering, and Regulatory teams; Implement process improvements and CAPAs.
Seniority
Senior, hands-on IC
