Endotoxin method/low endotoxin recovery (LER) studies
Microbial Challenge/Hold time studies
Bacterial Retention Testing/Sterile Filtration Studies
Advancement of existing methods and implementation of alternative technologies, such as recombinant reagents for endotoxin testing and Monocyte Activation Test (MAT) for pyrogen testing
Evaluation of RMMs
Analyze and interpret experimental data, summarize study results, and assist with the preparation of protocols, technical assessments, reports
Maintain knowledge of current compendial and regulatory requirements applicable to microbiological testing and microbial control, including USP, Ph. Eur., JP, and relevant regulatory guidance (Annex 1, CFRs, etc.)
Collaborate with QC Microbiology, Process Development, Manufacturing, Quality and other functions to support the network
Participate in and represent Process Microbiology in scientific and cross-functional meetings, including communicating study progress, study results, and technical findings
Communicate effectively and efficiently with cross-functional team members, clients, and partner organizations
Support day-to-day laboratory operations, including maintaining laboratory supplies and inventory, coordinating ordering of materials, and ensuring appropriate supplies are available to support study execution
Basic Qualifications
Bachelor’s degree and 2 years microbiology, related biological science experience
Preferred Qualifications
Hands-on experience in microbiology and aseptic techniques.
Prior experience in Microbiological Quality Lab or similar microbiology laboratory environment
Demonstrate the ability to understand, apply, and evaluate microbiological principles
Experience with compendial microbiological methods, including bioburden, bacterial endotoxins, and/or sterility testing
Detail-oriented with strong laboratory documentation and technical writing skills.
Ability to independently organize and execute laboratory studies while effectively managing multiple priorities and timelines
Effective written and verbal communication skills with the ability to work independently as well as collaboratively in cross-functional teams
Proficiency with tools used to organize and manage projects and data, such as SharePoint and Smartsheet
