Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days
Core
Execute downstream purification operations (column chromatography, TFF, viral filtration, viral inactivation, conjugation) and support facility startup/commissioning for bulk drug substance manufacturing.
Role type
Senior Associate Manufacturing (Downstream)
Builds
Bulk drug substance for biotechnology products
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
physical/clinical work
Required skills
cGMP compliance, aseptic techniques, equipment operation, process monitoring, in-process sampling, CAPA implementation, cross-functional collaboration
Preferred skills
Biotech/pharma plant startup experience, downstream purification knowledge, EBR/MES system proficiency
Technologies
Column chromatography, TFF, viral filtration, viral inactivation, conjugation, EBR, MES, Delta V
Responsibilities
Perform hands-on manufacturing operations including set-up, cleaning, and sanitization; execute process tasks and complete Electronic Batch Records; support operational readiness, training, and startup activities; initiate quality observations and support investigations; collaborate with QA/QC, Engineering, and Regulatory teams; drive continuous improvement and safety compliance.
Seniority
Mid-level, hands-on IC
