Associate Manufacturing - Bulk Drug Substance Downstream - Days
Core
Execute hands-on downstream purification operations (column chromatography, TFF, viral filtration, etc.) in a biopharmaceutical manufacturing facility to produce bulk drug substances.
Role type
Associate Manufacturing Operator (Downstream)
Builds
Bulk drug substance for biopharmaceutical products
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
cGMP compliance, aseptic techniques, equipment operation and monitoring, electronic batch record completion, deviation documentation, process sampling
Preferred skills
Biotechnology/pharmaceutical industry experience, NC BioWorks Certification, EBR/MES system proficiency, Microsoft Office
Technologies
EBR, MES, Delta V, Electronic Quality Systems
Responsibilities
Execute manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment; Perform in-process sampling and complete Electronic Batch Records; Support facility startup, commissioning, and qualification activities; Initiate and document deviations and quality events; Maintain compliance with SOPs and safety protocols
Seniority
Entry-level to Junior, hands-on IC
