Microbiology Lead
Core
Lead microbiology expertise for a 3-year commercialization program of a new sterile cartridge-filling product line.
Role type
Senior Microbiology Lead (Sterile Manufacturing)
Builds
New sterile medical device product line
Domain
Pharmaceutical manufacturing / Sterile manufacturing
Required skills
Microbiology, Sterile manufacturing, GMP, Contamination control, Environmental monitoring, Regulatory compliance, Validation, Risk assessment, LIMS/gLIMS, Isolator technology
Preferred skills
FDA/IMB regulated facility experience, Cross-functional project management
Technologies
LIMS, gLIMS, MODA
Responsibilities
Provide microbiological oversight across the project lifecycle; Define and implement microbiology strategies aligned with sterile manufacturing requirements; Ensure compliance with GMP, regulatory standards, and data integrity principles; Oversee environmental monitoring, contamination control, and sterility assurance strategies; Support risk assessments related to microbiological and contamination risks; Collaborate with cross-functional teams for commercial launch readiness; Contribute to validation activities including sterilization, aseptic processes, and cleaning validation; Support regulatory submissions and inspections; Manage Microbiology Department SOPs, change controls, deviations, and IRFs.