Team Lead, QC Microbiology

Lead a quality control microbiology team at Thermo Fisher Scientific, overseeing analytical testing, regulatory compliance, and GMP standards in a pharmaceutical manufacturing environment. The role involves managing technical staff, implementing quality improvements, and interfacing with clients and regulatory bodies.

Responsibilities

• Lead quality control team to ensure product quality standards and regulatory compliance
• Implement quality improvements and troubleshoot technical issues within GMP framework
• Support team member development while managing efficient lab operations and testing timelines
• Maintain rigorous documentation of analytical results and testing data
• Interface with clients and regulatory bodies as subject matter expert

Requirements

• Advanced degree with no prior experience, or bachelor's degree plus 2 years pharmaceutical manufacturing/CDMO experience
• Experience in bioburden and endotoxin testing for pharmaceuticals
• Experience in environmental monitoring within ISO 8, 7, and 5 cleanroom environments
• 1-2 years demonstrated leadership experience managing technical teams preferred
• Expert knowledge of GMP regulations, ICH guidelines, and pharmacopeia standards
• Strong proficiency with analytical instrumentation, LIMS, and quality documentation systems
• Excellent project management, problem-solving, and interpersonal communication skills

Compensation: $31.73–$47.60 hourly, plus variable annual bonus