Position OverviewThis 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 ResponsibilitiesHands-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.
QualificationsRequired- 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 CompetenciesSterility 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
Pay Range: $84,000 - $126,000 per year
