Senior Associate - Biomanufacturing, Downstream/mRNA
Core
Provides process and technical leadership during the manufacturing of biopharmaceutical products, specifically mRNA, within a clean room environment.
Role type
Senior Associate, Biomanufacturing (Downstream/mRNA)
Builds
Biologics and mRNA drug substances for pharma/biotech clients
Domain
Biopharmaceuticals / mRNA production
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, batch production record execution, GMP compliance, cleanroom operations, troubleshooting, mentoring
Preferred skills
TrackWise, ComplianceWire, JD Edwards, DeltaV, Unicorn software, GMP manufacturing experience
Technologies
TrackWise, ComplianceWire, JD Edwards, DeltaV, Unicorn
Responsibilities
Perform advanced troubleshooting and basic Downstream purification for mRNA production; Follow manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs); Document all activities in accordance with Good Documentation Practices (GDPs); Recognize deviations and raise awareness through the Rapid Response process; Lead "Just Do It" (JDI) Continuous Improvement activities; Act as a formal mentor for junior team members; Participate in daily shift huddles and lead shift exchange activities; Perform general cleanroom housekeeping
Seniority
Senior, hands-on IC
