The Role
In this role, you will support microbiology method development and lifecycle activities within Analytical Development for mRNA-based vaccines and therapeutics. You will apply hands-on expertise in microbiological methods including bioburden, endotoxin, sterility, and environmental monitoring to execute method development, optimization, characterization, qualification, and validation studies. You will work closely with Analytical Development scientists and cross-functional partners to evaluate method performance, troubleshoot technical challenges, support investigations and regulatory questions, and advance robust microbiological methods toward implementation in Quality Control. Success in this role requires strong laboratory execution, scientific problem-solving, attention to data quality and documentation, and effective collaboration across CMC Development and Quality.
Here’s What You’ll Do
Execute microbiological method development, optimization, characterization, qualification, and validation studies for bioburden, endotoxin, sterility, environmental monitoring, and related microbiological methods.
Independently plan and execute defined experimental studies; analyze and interpret data, identify sources of variability, troubleshoot technical issues, and recommend experimental next steps.
Evaluate method performance and suitability for intended use across relevant materials and sample types to support development, qualification, validation, and method lifecycle activities.
Author and execute study protocols and methods and contribute to technical reports, development summaries, validation documentation, and other analytical documentation.
Perform microbiological testing as part of method development, qualification/validation studies, investigations, troubleshooting, and other non-routine technical assessments.
Support microbiological investigations, deviations, method troubleshooting, and root-cause assessments in partnership with AD, AS&T, QC, Quality, Process Development, and other cross-functional teams.
Provide microbiology technical support for development programs, including technical assessments, risk evaluations, regulatory questions/RTQs, and preparation of supporting data and documentation.
Support method transfer and implementation in internal and external QC laboratories and provide technical support during method lifecycle activities.
Contribute to the evaluation and implementation of alternative or rapid microbiological methods, new technologies, and automation approaches that improve method performance, efficiency, or turnaround time.
Communicate experimental results, conclusions, risks, and recommendations to technical and cross-functional stakeholders while maintaining high standards for laboratory safety, data integrity, and documentation.
Here’s What You’ll Need (Basic Qualifications)
M.S. in Microbiology, Biology, Molecular Biology, Biochemistry, Biotechnology, or a related field with 4+ years of relevant experience; or B.S./B.A. with 6+ years of relevant industry experience. Hands-on experience with microbiological methods and analytical method development, qualification, validation, or troubleshooting is required.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Hands-on experience with microbiological methods including bioburden, bacterial endotoxin, and sterility; environmental monitoring experience is desirable.
Experience developing, optimizing, characterizing, qualifying, or validating microbiological methods in a biotechnology or pharmaceutical environment.
Understanding of microbiological method performance, suitability, controls, interference, recovery, variability, and fitness for intended use.
Experience in troubleshooting microbiological methods and supporting laboratory investigations, deviations, and root-cause assessments.
Familiarity with USP and other applicable compendial and regulatory expectations for microbiological methods.
Experience supporting method…