Associate Director, Environment Monitoring and Microbiology (Biotech)

TL;DR

Associate Director, Environment Monitoring and Microbiology (Biotech): Managing the overall strategy, operations, and compliance of the QC Microbiology laboratory for allogeneic CAR T cell therapies with an accent on environmental monitoring, microbial testing programs, and GMP laboratory standards. Focus on qualifying equipment, driving method validations, and ensuring inspection readiness under high regulatory scrutiny.

Location: Onsite 5 days per week at manufacturing facility in Newark, CA. Must be authorized to work in the U.S.

Salary: $170,000–$210,000 per year

Company

Clinical-stage biotechnology company pioneering allogeneic CAR T cell (AlloCAR T) therapies for cancer and autoimmune diseases.

What you will do

• Lead strategy, planning, implementation, and daily operations of Environmental Monitoring (EM)/Microbiology program, including compliant testing of materials and products.
• Hire, develop, and manage QC microbiology staff to meet technical and GMP compliance needs.
• Oversee EM programs, microbiological methods, equipment, utilities monitoring, and rapid microbial technologies like MODA system.
• Drive qualification of QC microbiology equipment in collaboration with validation team.
• Make technical decisions on lab operations, review analytical data and documents for regulatory compliance.
• Serve as SME on all EM/Microbiology methods and maintain lab in constant inspection-ready state.

Requirements

• Bachelor’s degree in Microbiology or related field (advanced degree preferred) with 8+ years in biotech/pharma, including 4+ years in management.
• Strong experience with microbiological methods: sterility, bioburden, endotoxin, air monitoring, microbial ID, mycoplasma testing.
• Deep knowledge of cGMP, QC systems, aseptic process, contamination control, method development/validation.
• Experience with MODA, LIMS, lab automation, regulatory interactions, inspections, and technical writing.
• Authorized to work in the U.S.
• Excellent organizational, prioritization, communication, and teamwork skills.

Culture & Benefits

• Collaborative environment with talented team focused on innovative cell therapy.
• Competitive compensation including annual bonus and equity.
• Comprehensive health insurance, generous time off, and 2 annual company-wide holiday shutdowns.