Technical Group Leader, Downstream Manufacturing - Biologics - Eurofins CDMO Alphora, Inc.
Core
Lead downstream manufacturing operations for biologics, ensuring cGMP compliance and transferring processes from development to production.
Role type
Senior Technical Group Leader, Downstream Manufacturing
Builds
Clinical and commercial biologics materials
Domain
Biopharmaceutical CDMO, Bioprocessing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream bioprocessing expertise (chromatography, TFF/UF-DF, filtration, protein bioconjugation), cGMP compliance, process technology transfer, commissioning/qualification/validation (CQV), team leadership and mentoring, root-cause analysis, aseptic technique, SOP authoring
Preferred skills
Experience with AKTA and skid systems, buffer preparation, cross-functional collaboration with Upstream/QA/QC
Technologies
AKTA, skid systems, TFF/UF-DF, filtration systems
Responsibilities
Oversee downstream GMP activities and floor supervision, execute downstream experiments and manufacturing runs, lead technical investigations and root-cause analysis, coordinate process transfer from Development to GMP, train and mentor junior manufacturing staff, ensure inspection readiness and data integrity
Seniority
Senior, hands-on IC with leadership responsibilities
