Principal Scientist I, Microbiologist
Core
Provide technical leadership and oversight of the QC Microbiology team, managing environmental monitoring, contamination control, and microbiological testing for water, raw materials, in-process samples, and product release.
Role type
Senior IC microbiologist with supervisory responsibilities
Builds
Production quality data and compliance reports for biopharmaceutical and medical device products
Domain
Biopharmaceuticals / Medical Devices / Quality Control
Required skills
Microbiology, Environmental Monitoring, Contamination Control, Risk Assessments, Data Trending, Investigation Management, Change Controls, SOP Development, Validation, cGMP Compliance
Preferred skills
ADC Manufacturing, Lean Six Sigma, Laboratory Supervision
Technologies
Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS)
Responsibilities
Lead investigations, change controls, and improvement initiatives related to environmental control and contamination risks; Establish and maintain microbiology testing and qualification capabilities; Author, review, and approve SOPs, validation and qualification documents, specifications, investigations, and quality records; Support the QC Manager in supervising, planning, and reviewing of daily operations of assigned staff.
Seniority
Senior, hands-on IC with supervisory duties