Senior Microbiology Lead - GMP QC & Lab Growth

Actalent; West Palm Beach (FL); Hybrid; USD 151,743,000 - 165,305,000; Full time

Benefits offered by this job

Medical, dental & vision

Critical illness, accident & hospital

401(k) retirement plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

PTO / Vacation or Sick Leave

Job summary

Actalent is seeking a Senior QC Microbiologist to lead an expanding GMP-compliant analytical microbiology lab supporting pharmaceutical release, stability studies, and API testing. The role emphasizes technical leadership, SOP development, and cross-functional collaboration.

You will drive instrument qualification, environmental monitoring, and cGMP compliance while mentoring QC analysts and coordinating with QA and clients.

Qualifications

• Bachelor2 s 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.

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

Bachelor2 s degree in Microbiology or related; Masters preferred

Job description

Actalent is seeking a Senior QC Microbiologist to lead an expanding GMP-compliant analytical microbiology lab supporting pharmaceutical release, stability studies, and API testing. The role emphasizes technical leadership, SOP development, and cross-functional collaboration.

You will drive instrument qualification, environmental monitoring, and cGMP compliance while mentoring QC analysts and coordinating with QA and clients.