Quality Control Microbiology Associate Director
Core
Lead the Upper Merion Biopharma quality control microbiology laboratory, managing resource allocation, assay validation, and regulatory reporting for product release and manufacturing support.
Role type
Associate Director, Quality Control Microbiology
Builds
Biopharma products (specialty medicines and vaccines) via validated microbiological testing
Domain
Biopharmaceuticals / Microbiology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology testing, Assay validation, Regulatory compliance (GxP/FDA), Laboratory management, Team leadership, Technical transfer, Report compilation, SOP implementation
Preferred skills
Master's degree, Strategic prioritization, Cross-functional collaboration, Continuous improvement, Risk management
Technologies
LIMS, Bioburden testing equipment, Endotoxin testing systems, Validation software
Responsibilities
Plan and prioritize resource allocation for QC microbiology laboratory operations. Oversee bioburden, endotoxin, and other microbiology testing areas. Manage training of QC analysts and specialists. Transfer, qualify, validate, and implement new assays from development. Conduct laboratory investigations related to product testing. Compile reports for regulatory filings (IND, BLA, MAA). Review and release test results. Ensure full cGMP compliance and update regulatory documents.
Seniority
Senior, hands-on IC with leadership responsibilities