Development Scientist

Overview We are seeking an experienced Scientist with strong expertise in microbiology and bioassay development to support method development, troubleshooting, and validation activities in a GMP/CLIA-regulated environment. The ideal candidate will have a solid industry background in both microbiological and analytical methods and will play a critical role in supporting the testing of advanced products. Key Responsibilities -Lead and execute assay development, optimization, and troubleshooting. -Author SOPs and technical documentation in alignment with regulatory requirements. -Perform method validations following ICH guidelines (accuracy, precision, linearity). -Develop and refine microbiology protocols, including: Antimicrobial Effectiveness Testing (AET, USP ) Biological Indicator Testing Cleaning Validations Sterility and Bioburden Protocols Water Testing (TOC, Conductivity, Coliforms) Microbial identification (fungal testing, PCR, sequencing) -Conduct a variety of bioassays such as: qPCR Flow Cytometry ELISA (Luminex preferred) -Collaborate with cross-functional QC and analytical development teams. Ensure adherence to GMP/CLIA standards and contribute to continuous improvement initiatives. Required Qualifications MS or PhD in Microbiology, Molecular Biology, Biochemistry, or related discipline. Minimum 5 years of industry experience in a regulated (GMP/CLIA) environment . Strong background in microbiological methods with exposure to bioassays . Experience developing and validating assays per ICH guidelines. Demonstrated ability to independently design, troubleshoot, and improve analytical methods.