Scientist III, Quality Control Microbiology Sterile Operations

MannKind Corporation • Danbury, CT

1d

About The Position

This hands-on laboratory- and cleanroom-based position performs microbiological testing and environmental monitoring to support sterile drug product manufacturing, aseptic fill-finish operations, pre-filled syringes, and the FUROSCIX® Autoinjector. The role provides technical expertise in sterility assurance, contamination control, combination-product support, investigations, method lifecycle activities, and regulatory inspection readiness. The individual independently executes assigned testing and monitoring, documents results according to cGMP and data integrity requirements, troubleshoots technical issues, leads or supports investigations, and collaborates with Manufacturing, Quality Assurance, Engineering, Facilities, Validation, and Regulatory Affairs.

The position performs routine and non-routine microbiological tests, supports environmental monitoring and contamination-control activities in controlled areas, and provides direct microbiology support for sterile manufacturing and aseptic processing. It also supports manufacturing, testing, risk assessments, investigations, qualifications, and validation activities for FUROSCIX® pre-filled syringes and autoinjectors. The role authors and reviews technical and quality-system documents and supports audits and regulatory inspection readiness.

Work is performed in microbiology laboratories and controlled cleanroom environments. The position requires compliance with gowning, hygiene, aseptic behavior, laboratory safety, cGMP, approved procedures, and data integrity requirements. Occasional off-shift, weekend, or holiday work may be needed to support manufacturing schedules, aseptic operations, monitoring, investigations, or time-sensitive testing.

Requirements

• 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.
• Ability to work in microbiology laboratories and controlled cleanroom environments and comply with gowning, hygiene, and aseptic behavior requirements.
• Ability to stand or sit for extended periods and perform repetitive laboratory manipulations while using appropriate personal protective equipment.
• Ability to support manufacturing schedules, including occasional off-shift, weekend, or holiday activities when required.
• Ability to safely handle biological materials, laboratory chemicals, equipment, and samples in accordance with approved procedures.

Nice To Haves

• 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.

Responsibilities

• Perform routine and non-routine microbiological testing, 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 according to approved procedures.
• Execute and troubleshoot microbiological method transfer, verification, qualification, and validation activities.
• Lead disinfectant efficacy studies and author study reports.
• Review and interpret microbiological data and ensure complete, accurate, contemporaneous documentation in laboratory records and electronic systems, including LIMS.
• Operate, maintain, verify, and support qualification of microbiology laboratory equipment, including incubators, air samplers, particle counters, endotoxin systems, and sterility test equipment.
• Perform and support routine and event-driven environmental monitoring in ISO 5 (Grade A), ISO 7, and ISO 8 areas, including cleanrooms, isolators, RABS, filling suites, and other controlled areas.
• Perform viable active and passive air monitoring, non-viable active air monitoring, surface monitoring using swabs or contact plates, 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.
• Provide on-floor microbiology support during compounding, sterile filtration, aseptic filling, equipment and facility qualification, process validation, and PPQ activities.
• Perform environmental and personnel monitoring during aseptic process simulations (media fills) and support protocol execution, incubation, inspection, data review, and investigations.
• Support cleanroom qualification and requalification, including recovery studies and viable/non-viable monitoring.
• 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.
• Execute or support incoming, in-process, release, and stability-related device testing 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 combination-product investigations, changes, qualifications, and validation activities.
• 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 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.
• Perform other assignments as necessary.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior