Mid Level Microbiology Analyst Jobs
Mid level microbiology analyst jobs go to analysts ready to own testing protocols, mentor junior staff, and lead investigations from sample receipt through final reporting with minimal oversight. Openings are concentrated across Healthcare & Medical Services, Education, and Science & Research, with a mix of on-site, hybrid, and remote positions, and employers like Biogen, Cytiva, and Norton Healthcare hiring at this level now.
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Open roles10
Top stateTexas
Top employerBiogen
Top cityDallas, TX
Work type100% On-site
Top industryHealthcare
Showing 5 of 10+ Mid Level Microbiology Analyst jobs
Scientist III, Quality Control Microbiology Sterile Operations
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Added 1w ago
MannKind Corporation
Scientist III, Quality Control Microbiology Sterile Operations
Danbury, Connecticut
Added 1w ago
Quality Control Microbiology Sr Associate I
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Added 3w ago
Biogen
Quality Control Microbiology Sr Associate I
Research Triangle Park, North Carolina
Added 3w ago
Supervisor - Clinical Laboratory - Microbiology
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Added 3w ago
University of Mississippi Medical Center
Supervisor - Clinical Laboratory - Microbiology
Jackson, Mississippi
Added 3w ago
Laboratory Clinical Manager, Microbiology
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Added 1mo ago
Massachusetts General Hospital
Laboratory Clinical Manager, Microbiology
Boston, Massachusetts
Added 1mo ago
Microbiology Lab Services Manager
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Added 1mo ago
Mount Sinai Medical Center
Microbiology Lab Services Manager
Miami, Florida
Added 1mo ago
Added 1w ago
Scientist III, Quality Control Microbiology Sterile Operations
MannKind Corporation·Danbury, Connecticut
Job functions:
$84k - $126k/yr
5+ yrs exp.
Bachelor's degree in biology
Full Time
201-500 employees
Job Description
MannKind Corporation focuses on the development and commercialization of innovative therapeutic products and drug delivery devices that address serious unmet medical needs. We apply our formulation and device capabilities to develop convenient treatment options designed to reduce the burden of disease and improve patient care.
Position Overview
This is a hands-on laboratory and cleanroom-based position. The Scientist III, Quality Control Microbiology individual performs microbiological testing and environmental monitoring activities supporting sterile drug product manufacturing, aseptic fill-finish operations, pre-filled syringes, and the FUROSCIX® Autoinjector. The role also provides technical expertise for sterility assurance, contamination control, combination-product support, investigations, method lifecycle activities, and regulatory inspection readiness.
The individual is expected to independently execute assigned testing and monitoring activities, document results in accordance with cGMP and data integrity requirements, troubleshoot technical issues, lead or support investigations, and collaborate with Manufacturing, Quality Assurance, Engineering, Facilities, Validation, and Regulatory Affairs.
Key Responsibilities
Hands-On Microbiological Testing
- Perform all routine and non-routine microbiological tests including sterility testing, Bacterial Endotoxin Testing (BET), bioburden, microbial identification, growth promotion, and water or utility monitoring.
- Prepare samples, media, reagents, standards, controls, and laboratory equipment; incubate, examine, enumerate, and document test articles as required by approved procedures.
- Execute microbiological method transfer, verification, qualification, validation; troubleshoot associated activities.
- Lead disinfectant efficacy studies and author study report
- Review and interpret microbiological data and ensure complete, accurate, and contemporaneous documentation in laboratory records and electronic systems (LIMS).
- Operate, maintain, verify, and support qualification of microbiology laboratory equipment, including incubators, air samplers, particle counters, endotoxin systems, and sterility test equipment.
Environmental Monitoring and Contamination Control
- Perform and support routine / event-driven environmental monitoring in ISO 5 (Grade A), ISO 7, and ISO 8 areas for compounding, aseptic filling, and related operations (cleanrooms, isolators, RABS, filling suites, and other controlled areas) while following aseptic gowning and behavior requirements.
- Perform viable (active and passive) and non-viable air monitoring (active), surface monitoring (swab / contact plate), and personnel monitoring.
- Evaluate environmental monitoring results, assist with alert/action-level assessments, perform trend analyses, and support organism identification and objectionability assessments.
- Support development, implementation, and continuous improvement of the site Contamination Control Strategy.
Sterile Manufacturing and Aseptic Processing Support
- Provide direct, on-floor microbiology support during compounding, sterile filtration, aseptic filling, equipment qualification, facility qualification, process validation, and PPQ activities.
- Perform environmental and personnel monitoring during aseptic process simulations (APS – “media fills”) and support protocol execution, incubation, inspection, data review, and investigation activities.
- Support cleanroom qualification and requalification, including recovery studies and viable/non-viable monitoring activities.
- Support microbiological monitoring and qualification of clean utilities, including purified water / WFI, clean steam, and compressed gases, as applicable.
Autoinjector, Pre-Filled Syringe, and Combination-Product Support
- Provide hands-on and technical microbiology support for FUROSCIX® pre-filled syringe and autoinjector manufacturing, assembly, packaging, validation, and commercial readiness activities.
- Execute or support incoming, in-process, release, and stability-related device testing, as assigned, in accordance with approved methods and specifications.
- Support microbiological risk assessments for device components, sterile primary packaging, assembly processes, storage, and distribution.
- Collaborate with Device Development, Engineering, Manufacturing, and Quality Assurance on investigations, changes, qualifications, and validation activities affecting the combination product.
Investigations, Quality Systems, and Compliance
- Lead or support investigations involving environmental monitoring excursions, sterility or endotoxin failures, bioburden events, contamination events, objectionable organisms, deviations, OOT, and OOS results.
- Perform root cause analysis, document scientifically sound conclusions, and develop or implement corrective and preventive actions.
- Author and review SOPs, test methods, specifications, protocols, technical reports, risk assessments, change controls, and validation documents.
- Support regulatory inspections, customer audits, internal audits, and inspection readiness activities as a technical resource for microbiology and sterile operations.
- Work in accordance with applicable cGMP requirements, approved procedures, laboratory safety practices, and data integrity principles.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Qualifications
Required
- Bachelor's degree in microbiology, Biology, Pharmaceutical Sciences, or a related life science discipline with at least 7 years of relevant experience; or a Master's degree with at least 5 years of relevant experience.
- Hands-on QC Microbiology experience in a cGMP-regulated pharmaceutical, biotechnology, or combination-product environment.
- Demonstrated practical experience with sterile drug product manufacturing, aseptic processing, and environmental monitoring in ISO 5 (Grade A) areas.
- Hands-on experience with sterility testing, BET, bioburden, microbial identification, growth promotion, and cleanroom monitoring techniques.
- Ability and willingness to routinely perform laboratory testing, cleanroom environmental monitoring, aseptic gowning, and on-floor manufacturing support.
- Working knowledge of FDA cGMP requirements, USP microbiology-related chapters, EU GMP Annex 1, contamination control, and data integrity expectations.
- Strong technical writing, investigation, problem-solving, communication, and cross-functional collaboration skills.
Preferred
- Experience with pre-filled syringes, autoinjectors, drug-device combination products, or sterile injectable products.
- Hands-on experience with Container Closure Integrity Testing and associated method validation or transfer.
- Experience supporting media fills, isolators, RABS, cleanroom qualification, smoke studies, or aseptic process validation.
- Experience supporting regulatory inspections and responding to microbiology- or aseptic processing-related observations.
- Knowledge of rapid microbiological methods, laboratory computerized systems, and LIMS.
Physical and Work Environment Requirements
- Ability to work in microbiology laboratories and controlled cleanroom environments.
- Comply with gowning, hygiene, and aseptic behavior requirements.
- Ability to stand or sit for extended periods and perform repetitive laboratory manipulations with appropriate personal protective equipment.
- Ability to support manufacturing schedules, including occasional off-shift, weekend, or holiday activities when required for aseptic operations, environmental monitoring, investigations, or time-sensitive testing.
- Ability to safely handle biological materials, laboratory chemicals, equipment, and samples in accordance with approved procedures.
Key Competencies
Sterility Assurance | Hands-On Microbiological Testing | Environmental Monitoring | Contamination Control | Aseptic Processing | Autoinjector and Pre-Filled Syringe Technologies | Container Closure Integrity | Investigation and Root Cause Analysis | Technical Writing | Cross-Functional Collaboration
Equal Employment Opportunity
MannKind Corporation is an equal opportunity employer. Employment decisions are based on business needs, job requirements, and individual qualifications, without regard to any status protected by applicable law.
MannKind Corporation
Scientist III, Quality Control Microbiology Sterile Operations
Danbury, Connecticut
Added 1w ago201-500 employees
Job functions:
$84k - $126k/yr
5+ yrs exp.
Bachelor's degree in biology
Full Time
Job Description
MannKind Corporation focuses on the development and commercialization of innovative therapeutic products and drug delivery devices that address serious unmet medical needs. We apply our formulation and device capabilities to develop convenient treatment options designed to reduce the burden of disease and improve patient care.
Position Overview
This is a hands-on laboratory and cleanroom-based position. The Scientist III, Quality Control Microbiology individual performs microbiological testing and environmental monitoring activities supporting sterile drug product manufacturing, aseptic fill-finish operations, pre-filled syringes, and the FUROSCIX® Autoinjector. The role also provides technical expertise for sterility assurance, contamination control, combination-product support, investigations, method lifecycle activities, and regulatory inspection readiness.
The individual is expected to independently execute assigned testing and monitoring activities, document results in accordance with cGMP and data integrity requirements, troubleshoot technical issues, lead or support investigations, and collaborate with Manufacturing, Quality Assurance, Engineering, Facilities, Validation, and Regulatory Affairs.
Key Responsibilities
Hands-On Microbiological Testing
- Perform all routine and non-routine microbiological tests including sterility testing, Bacterial Endotoxin Testing (BET), bioburden, microbial identification, growth promotion, and water or utility monitoring.
- Prepare samples, media, reagents, standards, controls, and laboratory equipment; incubate, examine, enumerate, and document test articles as required by approved procedures.
- Execute microbiological method transfer, verification, qualification, validation; troubleshoot associated activities.
- Lead disinfectant efficacy studies and author study report
- Review and interpret microbiological data and ensure complete, accurate, and contemporaneous documentation in laboratory records and electronic systems (LIMS).
- Operate, maintain, verify, and support qualification of microbiology laboratory equipment, including incubators, air samplers, particle counters, endotoxin systems, and sterility test equipment.
Environmental Monitoring and Contamination Control
- Perform and support routine / event-driven environmental monitoring in ISO 5 (Grade A), ISO 7, and ISO 8 areas for compounding, aseptic filling, and related operations (cleanrooms, isolators, RABS, filling suites, and other controlled areas) while following aseptic gowning and behavior requirements.
- Perform viable (active and passive) and non-viable air monitoring (active), surface monitoring (swab / contact plate), and personnel monitoring.
- Evaluate environmental monitoring results, assist with alert/action-level assessments, perform trend analyses, and support organism identification and objectionability assessments.
- Support development, implementation, and continuous improvement of the site Contamination Control Strategy.
Sterile Manufacturing and Aseptic Processing Support
- Provide direct, on-floor microbiology support during compounding, sterile filtration, aseptic filling, equipment qualification, facility qualification, process validation, and PPQ activities.
- Perform environmental and personnel monitoring during aseptic process simulations (APS – “media fills”) and support protocol execution, incubation, inspection, data review, and investigation activities.
- Support cleanroom qualification and requalification, including recovery studies and viable/non-viable monitoring activities.
- Support microbiological monitoring and qualification of clean utilities, including purified water / WFI, clean steam, and compressed gases, as applicable.
Autoinjector, Pre-Filled Syringe, and Combination-Product Support
- Provide hands-on and technical microbiology support for FUROSCIX® pre-filled syringe and autoinjector manufacturing, assembly, packaging, validation, and commercial readiness activities.
- Execute or support incoming, in-process, release, and stability-related device testing, as assigned, in accordance with approved methods and specifications.
- Support microbiological risk assessments for device components, sterile primary packaging, assembly processes, storage, and distribution.
- Collaborate with Device Development, Engineering, Manufacturing, and Quality Assurance on investigations, changes, qualifications, and validation activities affecting the combination product.
Investigations, Quality Systems, and Compliance
- Lead or support investigations involving environmental monitoring excursions, sterility or endotoxin failures, bioburden events, contamination events, objectionable organisms, deviations, OOT, and OOS results.
- Perform root cause analysis, document scientifically sound conclusions, and develop or implement corrective and preventive actions.
- Author and review SOPs, test methods, specifications, protocols, technical reports, risk assessments, change controls, and validation documents.
- Support regulatory inspections, customer audits, internal audits, and inspection readiness activities as a technical resource for microbiology and sterile operations.
- Work in accordance with applicable cGMP requirements, approved procedures, laboratory safety practices, and data integrity principles.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Qualifications
Required
- Bachelor's degree in microbiology, Biology, Pharmaceutical Sciences, or a related life science discipline with at least 7 years of relevant experience; or a Master's degree with at least 5 years of relevant experience.
- Hands-on QC Microbiology experience in a cGMP-regulated pharmaceutical, biotechnology, or combination-product environment.
- Demonstrated practical experience with sterile drug product manufacturing, aseptic processing, and environmental monitoring in ISO 5 (Grade A) areas.
- Hands-on experience with sterility testing, BET, bioburden, microbial identification, growth promotion, and cleanroom monitoring techniques.
- Ability and willingness to routinely perform laboratory testing, cleanroom environmental monitoring, aseptic gowning, and on-floor manufacturing support.
- Working knowledge of FDA cGMP requirements, USP microbiology-related chapters, EU GMP Annex 1, contamination control, and data integrity expectations.
- Strong technical writing, investigation, problem-solving, communication, and cross-functional collaboration skills.
Preferred
- Experience with pre-filled syringes, autoinjectors, drug-device combination products, or sterile injectable products.
- Hands-on experience with Container Closure Integrity Testing and associated method validation or transfer.
- Experience supporting media fills, isolators, RABS, cleanroom qualification, smoke studies, or aseptic process validation.
- Experience supporting regulatory inspections and responding to microbiology- or aseptic processing-related observations.
- Knowledge of rapid microbiological methods, laboratory computerized systems, and LIMS.
Physical and Work Environment Requirements
- Ability to work in microbiology laboratories and controlled cleanroom environments.
- Comply with gowning, hygiene, and aseptic behavior requirements.
- Ability to stand or sit for extended periods and perform repetitive laboratory manipulations with appropriate personal protective equipment.
- Ability to support manufacturing schedules, including occasional off-shift, weekend, or holiday activities when required for aseptic operations, environmental monitoring, investigations, or time-sensitive testing.
- Ability to safely handle biological materials, laboratory chemicals, equipment, and samples in accordance with approved procedures.
Key Competencies
Sterility Assurance | Hands-On Microbiological Testing | Environmental Monitoring | Contamination Control | Aseptic Processing | Autoinjector and Pre-Filled Syringe Technologies | Container Closure Integrity | Investigation and Root Cause Analysis | Technical Writing | Cross-Functional Collaboration
Equal Employment Opportunity
MannKind Corporation is an equal opportunity employer. Employment decisions are based on business needs, job requirements, and individual qualifications, without regard to any status protected by applicable law.
See All 10 Mid Level Microbiology Analyst Jobs
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Who's Hiring
Top Industries Hiring
- Healthcare & Medical Services
- Education
- Science & Research
Mid Level Microbiology Analyst Jobs: Frequently Asked Questions
How do I get a mid level microbiology analyst job?
Position yourself around ownership, not just task completion. Highlight projects where you led the work, resolved deviations, or trained colleagues, and make sure your resume reflects hands-on experience with methods like PCR, microbial identification, or environmental monitoring. Certifications in GMP or laboratory quality systems help distinguish your application in regulated industries. Tailor each application to the specific product area or regulatory environment the employer works in.
Which companies hire mid level microbiology analysts?
Companies hiring mid level microbiology analysts right now include Biogen, Cytiva, and Norton Healthcare, based on current listings on Migrate Mate as of November 2026. Hiring at this level comes primarily from pharmaceutical and biotech manufacturers, contract testing labs, and food and beverage producers with active quality and compliance programs.
Are there remote mid level microbiology analyst jobs?
Yes, though most microbiology analyst roles require at least some on-site presence due to laboratory work. About 0% of mid level microbiology analyst openings are remote or hybrid as of November 2026, and those positions tend to involve data review, regulatory documentation, or quality oversight rather than bench work. Hybrid schedules are more common than fully remote arrangements at this level.
How do I move up to a mid level microbiology analyst role?
Moving into a mid level microbiology analyst role comes from building consistent depth in a specific area, whether that is sterility testing, environmental monitoring, or method development, and demonstrating you can handle work independently. Taking ownership of a validation study, contributing to a CAPA, or cross-training across laboratory functions shows the progression hiring managers look for when evaluating candidates for advancement.
Which industries hire the most mid level microbiology analysts?
Mid Level microbiology analyst roles concentrate in Healthcare & Medical Services, Education, and Science & Research, based on current listings on Migrate Mate as of November 2026. These sectors drive consistent hiring at the mid level because their products require ongoing microbiological testing to meet safety, quality, and regulatory compliance standards.