Senior Microbiologist: QC Leader in GMP Microbiology

Merck Group; Carlsbad (CA); On-site; USD 66,000 - 99,000; Full time

Benefits offered by this job

Health Insurance

PTO

Retirement contributions

Perquisites

Job summary

MilliporeSigma in the United States seeks a Senior Microbiologist to join the Quality Control Microbiology team in a GMP viral-vector manufacturing setting.

You will lead method/ equipment implementation, technical studies, investigations and CAPA activities while guiding analysts and collaborating with Manufacturing, QA, Process Development, Engineering, Validation and client teams to ensure compliant, reliable results.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Biochemistry or related life-science discipline.
• 7+ years of GMP microbiology experience in regulated labs supporting biologics or viral-vector manufacturing.
• Experience in investigations, CAPAs, change controls, and ALCOA+ data integrity.

Responsibilities

• Act as SME for microbiology testing and environmental monitoring in GMP viral-vector manufacturing.
• Lead method/equipment implementation, technical studies, investigations, and CAPA/change-control activities.
• Provide technical direction to analysts and collaborate with Manufacturing, QA, Process Development, Engineering and Validation.
• Lead microbiology lab testing (bioburden, endotoxin, growth promotion, identification) and trend reviews to drive CAPAs.

Skills

Microbiology

GMP

Environmental monitoring

Investigations

CAPA

Change Control

Cross-functional collaboration

Education

Bachelor’s in Microbiology/Biology/Biochemistry

High school diploma + 9+ years GMP microbiology

Tools

Laboratory methods

USP/EP/JP knowledge

Job description

MilliporeSigma in the United States seeks a Senior Microbiologist to join the Quality Control Microbiology team in a GMP viral-vector manufacturing setting.

You will lead method/ equipment implementation, technical studies, investigations and CAPA activities while guiding analysts and collaborating with Manufacturing, QA, Process Development, Engineering, Validation and client teams to ensure compliant, reliable results.