Sr Microbiologist

Actalent; West Palm Beach (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Actalent is seeking a Sr QC Microbiologist to provide technical leadership for a growing analytical microbiology laboratory supporting pharmaceutical product release, API batch release, and stability studies. The role involves leading the design and expansion of GMP-compliant operations, selecting and validating instrumentation (IQ/OQ/PQ), and developing SOPs, protocols, and training programs.

You will partner with QA, support investigations, audits, and cGMP compliance while expanding testing

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

Job description

• Environmental monitoring

Actalent is Hiring a Sr Microbiologist / Growth Opportunity within a Company!!

Job Description

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.

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.

Essential Skills

• Microbiology
• Environmental monitoring
• Aseptic technique
• Bioburden testing
• Sterilization
• Endotoxin testing
• Sterility testing
• Biology