Mid Level Microbiology Specialist Jobs
Mid level microbiology specialist jobs go to professionals ready to own experimental workflows end to end, interpret complex data with minimal oversight, and mentor junior lab members on technique and protocol. Openings are concentrated across Healthcare & Medical Services, Education, and Science & Research, with a mix of on-site, remote, and hybrid settings, 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 Specialist 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.
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Who's Hiring
Top Industries Hiring
- Healthcare & Medical Services
- Education
- Science & Research
Mid Level Microbiology Specialist Jobs: Frequently Asked Questions
How do I get a mid level microbiology specialist job?
Position yourself by highlighting hands-on ownership: protocols you developed, studies you led independently, and results that influenced product or research decisions. Tailor your resume to show depth in a specific area, such as environmental testing, QC microbiology, or fermentation, rather than broad exposure. Certifications in aseptic technique, GMP compliance, or relevant instrumentation also sharpen your profile against other candidates at this stage.
Which companies hire mid level microbiology specialists?
Companies hiring mid level microbiology specialists right now include Biogen, Cytiva, and Norton Healthcare, based on current listings on Migrate Mate as of November 2026. At this level, you'll find openings at pharmaceutical manufacturers, food safety firms, clinical diagnostics labs, and biotech companies scaling up their quality and R&D teams.
Are there remote mid level microbiology specialist jobs?
Yes, though most microbiology specialist roles require at least some on-site lab work. About 0% of mid level microbiology specialist openings are remote or hybrid as of November 2026, with fully remote positions typically concentrated in regulatory affairs, data analysis, or technical writing functions within the field.
How do I move up to a mid level microbiology specialist role?
Moving from entry level to mid level takes deliberate depth-building over your first few years. Focus on owning complete experiments or testing cycles rather than supporting others, documenting your contributions to SOPs or compliance audits, and demonstrating measurable outcomes, such as reduced contamination rates or faster turnaround times. Consistently taking on independent projects and asking for increased scope signals readiness for mid level responsibility.
Which industries hire the most mid level microbiology specialists?
Mid Level microbiology specialist roles concentrate in Healthcare & Medical Services, Education, and Science & Research, based on current listings on Migrate Mate as of November 2026. These sectors drive hiring at this level because they require ongoing quality assurance, regulatory compliance, and product safety validation that depend on experienced microbiologists working with real autonomy.