Job Description

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 <51>)
• 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.

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