Director QC Microbiology: Cell Therapy GMP Leader

MADE Scientific Inc; Eagleville (PA); On-site; USD 150,000 - 190,000; Full time

Job summary

Made Scientific Inc. seeks a Director of Quality Control Microbiology to lead the QC Operations team onsite in East Norriton, PA. The role focuses on releasing assays for cell therapy products with hands-on expertise in Flow Cytometry, PCR, Microbiology, rapid sterility testing, and bioassays.

You will drive regulatory compliance, Lean Lab initiatives, and cross‑functional collaboration to ensure timely, accurate data and client satisfaction, supporting GMP‑compliant testing and audits.

Qualifications

• Requires advanced degree in sciences with 5+ years in GMP QC or analytical labs and 3–5+ years in leadership within CDMO or regulated biotech.
• Hands-on expertise with Flow Cytometry, PCR, Microbiology, Rapid Sterility Testing, and Bioassays.
• Proven ability to lead and manage QC teams, ensure regulatory compliance, and drive lean lab improvements.

Responsibilities

• Lead and mentor a high‑performing QC Operations team in GMP‑compliant release testing.
• Provide strategic direction for all QC functions and ensure timely, high‑quality results.
• Oversee day‑to‑day QC lab operations, driving efficiency and accountability.
• Serve as technical leader for release assays including Flow Cytometry, PCR, Microbiology, Sterility, Bioassays.
• Manage staffing, workload, and performance alignment with business goals.

Skills

Leadership

GMP compliance

QC operations

Flow Cytometry

PCR

Bioassays

Lean lab

Education

Advanced degree in science

Tools

LIMS

ELN

Job description

Made Scientific Inc. seeks a Director of Quality Control Microbiology to lead the QC Operations team onsite in East Norriton, PA. The role focuses on releasing assays for cell therapy products with hands-on expertise in Flow Cytometry, PCR, Microbiology, rapid sterility testing, and bioassays.

You will drive regulatory compliance, Lean Lab initiatives, and cross‑functional collaboration to ensure timely, accurate data and client satisfaction, supporting GMP‑compliant testing and audits.