Senior Associate - Bulk Drug Substance Manufacturing Services - Days
Core
Senior Associate supporting startup and steady-state operations of a bulk drug substance manufacturing facility, focusing on material handling, solution preparation, and equipment operations.
Role type
Senior IC manufacturing associate (pharmaceuticals/biotech)
Builds
Bulk drug substance for oncology, inflammation, general medicine, and rare disease patients
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, aseptic techniques, equipment operation and cleaning, process monitoring, deviation reporting, CAPA implementation, SOP drafting, cross-functional collaboration
Preferred skills
Biotech/pharma plant startup experience, NC BioWorks Certification, solution preparation expertise, inventory control, EBR/MES system proficiency
Technologies
EBR, MES, Delta V, Electronic Quality Systems
Responsibilities
Weigh and dispense raw materials; prepare media, buffers, and solutions; perform parts washing and autoclave operations; monitor critical process tasks; conduct in-process sampling; maintain cGMP documentation; support staff training and qualification; drive continuous improvement initiatives
Seniority
Senior, hands-on IC