Senior QC Microbiology Scientist - Sterile Operations

MannKind Corporation; Danbury (CT); On-site; USD 110,000 - 140,000; Full time

Job summary

MannKind Corporation is seeking a Scientist III, Quality Control Microbiology, to perform microbiological testing and environmental monitoring in support of sterile drug product manufacturing and FUROSCIX autoinjector assembly. The role requires independent execution, data integrity, and collaboration across Manufacturing, QA, Engineering, and Regulatory Affairs.

The successful candidate will lead investigations, troubleshoot issues, and ensure compliance with cGMP requirements in ISO 5

Qualifications

• Bachelor's degree in microbiology or related life science with 7+ years of relevant experience; or a Master's with 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.
• Strong technical writing, investigation, problem-solving, communication, and cross-functional collaboration skills.

Responsibilities

• Perform routine and non-routine microbiological tests including sterility 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.
• 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 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.
• 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.
• 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.

Skills

QC Microbiology

Sterility testing

Environmental monitoring

Gowning & aseptic technique

Troubleshooting

Technical writing

Cross-functional collaboration

FDA cGMP knowledge

Education

Bachelor's degree in Microbiology

Master's degree in related field

Tools

LIMS

Sterility testing equipment

Incubators

Air samplers

Endotoxin systems

Job description

MannKind Corporation is seeking a Scientist III, Quality Control Microbiology, to perform microbiological testing and environmental monitoring in support of sterile drug product manufacturing and FUROSCIX autoinjector assembly. The role requires independent execution, data integrity, and collaboration across Manufacturing, QA, Engineering, and Regulatory Affairs.

The successful candidate will lead investigations, troubleshoot issues, and ensure compliance with cGMP requirements in ISO 5