Scientist, Analytical R&D; Microbiologist

Position: Scientist, Analytical R&D (Microbiologist)
* Perform routine viable and non‑viable Environmental Monitoring of classified cleanroom areas (Grad A-D), including surfaces, air, and equipment.
* Conduct active air, passive air (settle plates), surface sampling, in accordance with site EM programs and GMP requirements.
* Operate and maintain EM instruments (e.g., viable air samplers, particle counters, RODAC plates, isolator/BSC environmental sampling tools).
* Execute aseptic sampling techniques to ensure data integrity and contamination‑free sample collection.
* Perform utility sampling/testing (WFI, purified water, clean steam) and support routine water system monitoring.
* Perform microbiology laboratory testing associated with EM samples, including bioburden, microbial identification, and endotoxin testing.
* Trend, analyze, and interpret EM data; escalate atypical or out‑of‑trend (OOT) results and support investigations.
* Participate in deviation investigations, root cause assessments, and CAPA development related to environmental or microbiological events.
* Maintain accurate documentation of sampling activities in compliance with ALCOA and data‑integrity principles.
* Conduct microbiology finished goods testing and biological indicator (BIs) testing
* Conduct the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles
* Partner with internal stakeholders and partners, including Quality, Pipeline, and Operations.
* Perform second scientist review microbiology experiments in line with GMP expectations
* Support internal and external compliance audit activities.
* Conduct other job duties as per management assignments/business requirement.
* Be flexible weekday work hours and weekend support as needed
* Adaptability* Biological Sciences
* Environmental Monitoring
* GMP Compliance
* Good Manufacturing Practices (GMP)
* Laboratory Information Management System (LIMS)
* Laboratory Techniques
* Microbiological Tests
* Aseptic techniques
* Standard Operating Procedure (SOP)
* Interpersonal Relationship
* Self-Motivation
* Problem Solving
* Effective Communication
* Team Player
* BS degree in Microbiology or related Biological Sciences, with 3+ years of direct microbiological testing within GMP experience OR
* MS degree Microbiology or related Biological Sciences with 2+ years of pharmaceutical industry experience
* A proven record of microbiology laboratory experience.
* Excellent written and oral communication skills.
* Strong interpersonal skills are necessary to qualify for this role.
* Knowledge and experience of microbiology testing in context of, environmental monitoring, aseptic manufacturing, and utilities testing in a GMP environment.
* Knowledge of current microbiology industry guidelines and compendia.
* Knowledge in nonsterile and aseptic manufacturing and associated GMP product testing.
* Experience in supporting quality investigations in the microbiology discipline.
* Experience with MODA, SAP, Veeva, LIMS is a plus.
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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