QC Microbiology Manager: Lead Testing, Compliance & Team

Made Scientific, Inc.; East Norriton Township (Montgomery County); On-site; USD 110,000 - 160,000; Full time

Job summary

Made Scientific, Inc. is seeking a Manager of Quality Control (QC) Microbiology to lead the QC microbiology laboratory, partner with Facilities to meet calibration timelines, and ensure housekeeping is maintained in a state of compliance.

The role covers release and stability testing, environmental monitoring oversight, deviation handling, CAPA processes, and SOP management within a GMP cell-therapy CDMO environment. Strong leadership and cGMP expertise are required.

Qualifications

• Bachelor's degree in Microbiology, Biology, Life Sciences or related scientific discipline required.
• 5+ years of progressive QC Microbiology experience in biotech, pharma, cell therapy, or other cGMP environment.
• Experience leading or developing laboratory personnel.
• Strong knowledge of cGMP, microbiological testing, environmental monitoring, and regulatory guidelines.
• Experience with environmental/utility monitoring in GMP manufacturing.
• Experience with microbiological method qualification, validation, verification, and implementation.
• Experience with product release and microbiological safety testing (endotoxin, mycoplasma, rapid methods).
• Experience authoring/reviewing SOPs, protocols, reports, and controlled lab documents.
• Experience supporting deviations, investigations, CAPAs, change controls, root cause analysis.

Responsibilities

• Lead, manage and develop QC microbiology team members.
• Coordinate laboratory activities including release and stability testing to meet turnaround times.
• Draft/review/approve microbiology verification/qualification protocols and reports.
• Author/review/approve microbiological test methods and procedures.
• Support technical conversations with internal and external customers on microbiology methods.
• Assist in solving technical QC Microbiology issues.
• Author/review/approve deviations, CAPA and changes controls as needed.
• Oversee environmental monitoring programs.
• Establish environmental monitoring for new product introductions and risk assessments.
• Schedule, document, and report environmental monitoring activities and data.

Skills

Leadership

cGMP knowledge

Microbiology testing

Environmental monitoring

SOPs & docs

Cross-functional collaboration

Education

Bachelor's degree in Microbiology or Life Sciences

Job description

Made Scientific, Inc. is seeking a Manager of Quality Control (QC) Microbiology to lead the QC microbiology laboratory, partner with Facilities to meet calibration timelines, and ensure housekeeping is maintained in a state of compliance.

The role covers release and stability testing, environmental monitoring oversight, deviation handling, CAPA processes, and SOP management within a GMP cell-therapy CDMO environment. Strong leadership and cGMP expertise are required.