Associate Director, Quality Control - Bioassay
Core
Provide scientific and operational leadership for molecular and immunoassay testing teams to support the commercialization and safe release of biologics.
Role type
Associate Director, Quality Control (Bioassay)
Builds
Robust, compliant testing methods for biologics
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
qPCR, ELISA, cGMP compliance, root cause analysis, regulatory knowledge, team leadership, data integrity, assay validation, troubleshooting, strategic planning
Preferred skills
None stated
Technologies
qPCR, ELISA
Responsibilities
Lead and optimize molecular and immunoassay testing methods; Provide technical oversight for laboratory performance; Ensure launch readiness for clinical trials and commercial release; Monitor performance and quality metrics; Guide investigations into out-of-specification results; Review and approve protocols and validation reports; Coach and develop scientists; Collaborate cross-functionally with Quality, Manufacturing, and Regulatory teams
Seniority
Senior, hands-on IC with leadership responsibilities