ROLE SUMMARYThe 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 RESPONSIBILITIESMicrobiological 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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