Senior Microbiologist: GMP Lab Lead & Growth Opportunity

Actalent; Florida; Hybrid; USD 73,000 - 93,000; Full time

Benefits offered by this job

Comprehensive benefits

Continuing education support

Opportunities for advancement

Performance-based bonus eligibility

Job summary

Actalent is hiring a Sr Microbiologist to provide technical leadership for a growing analytical microbiology laboratory in Jupiter, FL. The role supports GMP-compliant operations for pharmaceutical product release, API batch release, and stability studies.

The candidate will drive instrument qualification, SOP development, method verifications, and environmental monitoring, while partnering with QA for investigations and audits. Hybrid work in Jupiter, FL offers growth into management.

Qualifications

• Bachelor's degree in Microbiology or related field; Master's preferred.
• Minimum seven years GMP pharmaceutical microbiology experience.
• Strong experience with technical writing, equipment qualification, and laboratory validation.
• 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.

Responsibilities

• 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 cleanrooms 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 laboratorys testing capabilities to meet operational and client needs.

Skills

Microbiology

Environmental monitoring

Aseptic technique

Bioburden testing

Sterilization

Endotoxin testing

Sterility testing

Biology

Quality control

Plating

Microbial testing

Microbiology laboratory operations

Education

Bachelor's degree in Microbiology or related field

Master's degree preferred

Job description

Actalent is hiring a Sr Microbiologist to provide technical leadership for a growing analytical microbiology laboratory in Jupiter, FL. The role supports GMP-compliant operations for pharmaceutical product release, API batch release, and stability studies.

The candidate will drive instrument qualification, SOP development, method verifications, and environmental monitoring, while partnering with QA for investigations and audits. Hybrid work in Jupiter, FL offers growth into management.