Senior QC Microbiology – Sterile Ops & Autoinjector

BioCT; Danbury (CT); On-site; USD 110,000 - 160,000; Full time

Job summary

MannKind Corporation seeks a Scientist III, Quality Control Microbiology to perform hands-on microbiology testing and environmental monitoring in support of sterile drug product manufacturing and FUROSCIX autoinjector projects.

The role requires strong cGMP knowledge, experience with ISO 5 environments, and collaboration across Manufacturing, QA, Engineering, and Regulatory Affairs. On-site presence in a sterile manufacturing setting is expected.

Qualifications

• Bachelor's degree in microbiology or life sciences with relevant experience (7+ years for BS, 5+ years for MS).
• Experience with pre-filled syringes, autoinjectors, or sterile injectable products.
• Hands-on experience with container closure integrity testing and method validation/transfer.
• QC microbiology experience in a cGMP-regulated pharmaceutical or biotech environment.
• Experience with sterile drug product manufacturing, aseptic processing, and environmental monitoring in ISO 5 areas.
• Knowledge of FDA cGMP, USP microbiology, EU GMP Annex 1, contamination control, and data integrity.

Responsibilities

• Perform routine and non-routine microbiological tests including sterility testing, BET, bioburden, microbial identification, growth promotion, and water/utility monitoring.
• Prepare samples, media, reagents, controls, and equipment; incubate, examine, enumerate, and document results per procedures.
• Execute microbiological method transfer, verification, qualification, validation; troubleshoot related activities.
• Lead disinfectant efficacy studies and author study reports.
• Review and interpret microbiology data, ensuring complete and accurate documentation in records and LIMS.
• Operate and maintain microbiology lab equipment and site qualification activities.

Skills

Sterility testing

Endotoxin testing

Bioburden analysis

Environmental monitoring

Aseptic processing

LIMS

cGMP knowledge

Technical writing

Education

Bachelor's degree in Microbiology

Master's degree in Microbiology

Tools

LIMS

Sterility testing equipment

Job description

MannKind Corporation seeks a Scientist III, Quality Control Microbiology to perform hands-on microbiology testing and environmental monitoring in support of sterile drug product manufacturing and FUROSCIX autoinjector projects.

The role requires strong cGMP knowledge, experience with ISO 5 environments, and collaboration across Manufacturing, QA, Engineering, and Regulatory Affairs. On-site presence in a sterile manufacturing setting is expected.