Director, QC Microbiology – Cell Therapy GMP Leader

Made Scientific, Inc.; Eagleville (PA); Vor Ort; USD 170.000 - 210.000; Vollzeit

Zusammenfassung

Made Scientific in East Norriton, PA seeks a Director of Quality Control Microbiology to lead the QC Operations team for cell therapy products. This on-site role requires hands-on leadership, ownership of release assays, and ensuring GMP-compliant testing and fast, accurate data reporting.

You will drive operational excellence, QA documentation, and regulatory compliance while collaborating with Manufacturing, Analytical Development, and Program Management to meet client timelines and quality

Qualifikationen

• Bachelor's degree in Biology, Microbiology, or related field; 3–5+ years in QC leadership.
• Experience leading QC operations in CDMO or regulated biotech.
• Hands-on with Flow Cytometry, PCR, and rapid sterility testing.
• Strong knowledge of GMP, FDA/EMA guidance.
• Proven track record in analytics and release testing.
• Willingness to travel and work flexible hours.

Aufgaben

• Lead, mentor, and develop the QC Operations team in alignment with GMP standards.
• Provide strategic direction for all QC functions and release testing.
• Oversee day-to-day QC lab operations, ensuring accuracy and compliance.
• Serve as technical and operational leader for release assays (Flow Cytometry, PCR, Microbiology, Sterility, Bioassays).
• Manage staffing, workload balance, and performance management.
• Lead audits and ensure documentation is audit-ready and traceable.

Kenntnisse

Leadership

GMP Knowledge

Regulatory Compliance

Quality Assurance

Cross-functional collaboration

Ausbildung

Bachelor’s degree in a scientific discipline

Master’s degree in a relevant field

Ph.D. in a scientific discipline

Tools

Flow Cytometry

qPCR

Microbiology

Bioassays

Rapid Sterility Testing

Jobbeschreibung

Made Scientific in East Norriton, PA seeks a Director of Quality Control Microbiology to lead the QC Operations team for cell therapy products. This on-site role requires hands-on leadership, ownership of release assays, and ensuring GMP-compliant testing and fast, accurate data reporting.

You will drive operational excellence, QA documentation, and regulatory compliance while collaborating with Manufacturing, Analytical Development, and Program Management to meet client timelines and quality