Senior Associate - Biomanufacturing, Downstream/mRNA
Core
Advanced troubleshooting and basic downstream purification for mRNA production in a GMP cleanroom environment.
Role type
Senior Associate, Biomanufacturing (Downstream/mRNA)
Builds
Biopharmaceutical products (mRNA)
Domain
Biotechnology / mRNA therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream purification, chromatography, tangential flow filtration (TFF), viral filtration, bulk drug substance filling, column packing/qualification, GMP compliance, batch record execution, deviation management, cleanroom operations, continuous improvement (CI), mentoring junior staff
Preferred skills
TrackWise, ComplianceWire, JD Edwards, DeltaV, Chromatography software (Unicorn), GMP manufacturing experience
Technologies
TrackWise, ComplianceWire, JD Edwards, DeltaV, Unicorn
Responsibilities
Perform advanced troubleshooting and basic downstream purification; Follow BPRs and SOPs in cGMP; Document activities in GDP-compliant records; Recognize deviations and raise awareness via Rapid Response; Lead Just Do It (JDI) continuous improvement activities; Mentor junior team members and act as onboarding buddy; Participate in shift huddles and exchange activities; Maintain cleanroom housekeeping and 5S standards
Seniority
Senior, hands-on IC