Job Description

ROLE SUMMARY
The Microbiologist serves as a technical expert within the QC Microbiology organization, with responsibility for microbiological method development, transfer, and validation for biologics (peptides, and proteins including mAbs) and small molecule products across raw materials, in process samples, bulk drug substance, and finished product. This role supports the design and establishment of microbiology capabilities within a new CDMO facility and performs routine and non routine QC testing, including bioburden, endotoxin, microbial enumeration, growth promotion, sterility testing, and environmental monitoring sample testing as needed.
The Microbiologist provides subject matter expertise in aseptic processing, sanitization, and sterility assurance, and supports validation of sterilization systems, cleaning processes, and environmental programs. The role leads microbiology investigations, authors technical documentation, ensures audit readiness, and mentors junior staff while maintaining strict adherence to cGMP, regulatory expectations, and site procedures.
ROLE RESPONSIBILITIES
Microbiological Method Development, Validation & Transfer
• Lead development, optimization, transfer, and validation of microbiological test methods including bioburden, endotoxin, sterility testing, microbial identification, and environmental monitoring methods.
• Design and execute validation protocols for sterilization processes, sanitization studies, biological indicators, container closure integrity, and microbial contamination controls.
• Support implementation and qualification of new microbiology laboratory equipment, test systems, and cleanroom monitoring technologies.
QC Microbiology Testing & Support
• Perform routine and non routine microbiological testing for raw materials, in process samples, bulk drug substances, and finished product (biologics and small molecules).
• Support sterility assurance programs, including microbial monitoring of aseptic manufacturing areas and investigation of environmental or product related excursions.
• Conduct microbiological and sanitization evaluations in support of Manufacturing and Cleaning Validation.
Deviation / Investigation Support & Technical Leadership
• Serve as SME for microbiological root cause analysis, data trending, and evaluation of OOS/OOT results.
• Write and review microbiological assessments, change control justifications, risk assessments, and investigation reports.
• Identify atypical results, recommend corrective actions, and independently implement solutions aligned with regulatory expectations.
• Provide guidance and training to junior microbiologists and laboratory staff in aseptic techniques, microbiological testing, and GMP compliance.
Documentation, Compliance & Continuous Improvement
• Author and revise SOPs, validation protocols, technical reports, method documents, and project plans.
• Ensure strict adherence to cGMP, data integrity, lab safety requirements, and site quality standards.
• Drive continuous improvement across microbiology workflows to improve efficiency, robustness, and regulatory readiness.
• Participate in regulatory, internal and client/vendor audits as a subject matter expert.
• Maintain a clean, well organized laboratory environment and ensure appropriate inventory of microbiology supplies.
Facility & Environmental Support
• Support environmental monitoring program execution, trending, and interpretation of viable and non viable data.
• Enter aseptic and controlled manufacturing areas to observe operations, evaluate aseptic behavior, and assess compliance with microbiological quality standards.
• Conduct periodic requalification of laboratory systems and environmental monitoring equipment.
• Other duties as assigned
QUALIFICATIONS

• BS or MS in Microbiology, Bacteriology, or a related biological science is required.
• Minimum 7 years of microbiology experience in a GMP pharmaceutical, biotechnology, aseptic manufacturing, or CDMO setting.
• Preferred: 3–5 years of experience in microbiological process
◦ control, aseptic operations, and cleanroom monitoring (viable and non viable particulates).
◦ Strong background supporting biologics (mAbs, proteins, peptides) highly preferred.
◦ Expertise in microbiological testing, including: Bioburden, sterility testing, endotoxin testing (LAL), microbial enumeration, growth promotion, microbial ID, container closure integrity, biological indicator qualification, and sanitization studies.
◦ Strong understanding of aseptic processing, cleanroom classifications, environmental monitoring programs, and contamination control strategies.
◦ Experience with sterilization systems (steam, dry heat, VHP), cleaning validation, and environmental data trending.
◦ Proficiency with standard microbiology instrumentation (incubators, isolators/RABS, particle counters, endotoxin readers, microscopes, etc.).
◦ Deep knowledge of cGMP, FDA/ICH guidance, USP/EP microbiology chapters, sterility assurance expectations, and data integrity requirements.
◦ Experience supporting regulatory inspections as an SME is highly desirable.
◦ Strong analytical problem solving skills with sound scientific judgment.
◦ Excellent technical writing and verbal communication skills.
◦ Ability to manage multiple priorities in a fast paced CDMO environment.
◦ Demonstrated leadership, mentoring ability, and commitment to quality, compliance, and continuous improvement.
◦ Ability to multi task across laboratory, manufacturing, and cross functional responsibilities
◦ support off shift/weekend work as needed to maintain operational continuity.

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