Senior Associate - Biomanufacturing, Downstream/mRNA
Core
Provides process and technical leadership for manufacturing biopharmaceutical products, specifically performing advanced troubleshooting and basic downstream purification for mRNA production in a clean room environment.
Role type
Senior Associate, Biomanufacturing (Downstream/mRNA)
Builds
Biopharmaceutical products (mRNA)
Domain
Biotechnology / Biomanufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Advanced troubleshooting, Downstream purification (IVT, chromatography, TFF, viral filtration), GMP compliance, Batch Production Records (BPR) execution, Standard Operating Procedures (SOP) adherence, Quality documentation, Deviation recognition, Cleanroom housekeeping, Mentorship
Preferred skills
GMP manufacturing experience, TrackWise, ComplianceWire, JD Edwards, DeltaV, Chromatography software (Unicorn)
Technologies
Microsoft Office, TrackWise, ComplianceWire, JD Edwards, DeltaV, Unicorn
Responsibilities
Perform advanced troubleshooting and basic downstream purification for mRNA production; Follow manufacturing BPRs and SOPs in accordance with cGMPs; Document all activities in BPRs and quality forms; Recognize deviations and raise awareness through the Rapid Response process; Lead "Just Do It" Continuous Improvement activities; Act as a formal mentor and onboarding buddy for junior team members; Participate in daily shift huddles and lead shift exchanges; Perform general cleanroom housekeeping and equipment maintenance.
Seniority
Senior, hands-on IC
