Sr Microbiologist

• Environmental monitoring

We are seeking an experienced Sr QC Microbiologist to provide technical leadership for a growing analytical microbiology laboratory. This role is pivotal in building and scaling GMP-compliant laboratory operations that support pharmaceutical product release, API batch release, and stability studies.

• Provide technical leadership for the analytical microbiology laboratory.
• Support the design, startup, and expansion of GMP-compliant laboratory operations.
• Lead the selection, qualification, and implementation of analytical instrumentation, including IQ, OQ, and PQ activities.
• Develop and maintain standard operating procedures, laboratory protocols, technical reports, and training programs.
• Perform and oversee method suitability, process verification, and microbiological testing activities.
• Establish and maintain environmental monitoring programs for clean rooms and separative devices.
• Partner with Quality Assurance to support investigations, corrective and preventive actions, and overall cGMP compliance.
• Serve as the microbiology subject‑matter expert during client interactions, regulatory inspections, and audits.
• Support laboratory accreditation activities, including alignment with ISO/IEC requirements.
• Establish programs for procurement, qualification, handling, storage, inventory control, traceability, and routine use of reference standard and challenge organisms.
• Ensure microbiological reference materials and laboratory practices comply with applicable USP requirements and recognized industry standards.
• Supervise, train, and professionally develop QC laboratory analysts as laboratory operations expand.
• Manage sample schedules, testing priorities, and laboratory workflow.
• Improve laboratory efficiency, throughput, and testing capacity.
• Oversee microbiological media, reference organisms, and related inventory.
• Coordinate activities with QC Chemistry and Quality Assurance.
• Support laboratory investigations and stability studies.
• Expand the laboratories testing capabilities to meet operational and client needs.

• Microbiology
• Environmental monitoring
• Aseptic technique
• Bioburden testing
• Sterilization
• Endotoxin testing
• Sterility testing
• Biology
• Quality control
• Plating
• Microbial testing
• Microbiology laboratory operations

• Bachelors degree in Microbiology or a related scientific discipline;
  Masters degree preferred.
• At least seven years of GMP pharmaceutical microbiology experience.
• Strong experience with technical writing, equipment qualification, and laboratory validation.
• Previous experience supporting regulatory inspections and client audits.
• Demonstrated knowledge of pharmaceutical microbiology and cGMP laboratory operations.
• Excellent communication, organization, leadership, and project‑management skills.
• Ability to manage multiple laboratory priorities in a growing operational environment.

The role is based in a clean room environment, offering a competitive salary, performance‑based bonus eligibility, comprehensive benefits, continuing‑education support, and opportunities for advancement into microbiology laboratory management or QC leadership. The position is in a startup environment with room for growth and expansion.

This is a Contract to Hire position based out of Boca Raton, FL.

The pay range for this position is $52.88 - $57.69/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors.

Eligibility…