Job Title: Senior Scientist, Microbiology

Job Description: We are seeking a highly skilled Senior Scientist specializing in Microbiology to lead and actively participate in the experimental design, method validation/qualification, and technical transfer activities for compendial methods across raw materials and finished products. As a pivotal member of our Quality Control team, you will perform both routine and non-routine testing, ensuring adherence to cGMP guidelines and leveraging lean six sigma principles for continuous improvement.

Key Responsibilities:

• Lead experimental design, compendia method qualifications, and assay transfers to ensure seamless project execution in the laboratory.
• Execute a variety of microbiological methods including Bioburden testing, Sterility Testing, and Microbial Limits Testing.
• Manage the stability program from sample pulling through testing, submission to external labs, and report generation.
• Train new hires and assist junior analysts in water and environmental sampling, gown qualification, and media fills.
• Oversee environmental performance qualifications for new cleanroom areas, conducting risk assessments and developing sampling plans.
• Analyze and interpret results, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Configure new analyses, products, and specifications in LIMS, liaising with vendors for laboratory needs.
• Author and review GMP data, including SOPs, test methods, validation protocols/reports, and technical reports.
• Monitor lifecycle of microbiology instruments, ensuring calibration and maintenance conform to specifications.
• Manage QC document archival and inventory control of consumables, media, and garments.
• Issue deviations, conduct laboratory investigations, and implement corrective actions in LIMS and QA-Track.
• Develop and deliver training programs for junior analysts and Micro Associates on technical concepts and methods.

Requirements:

• Bachelor of Science Degree in Biological or Environmental Sciences required; Master of Science degree preferred.
• Minimum 8 years of QC laboratory experience in pharmaceutical or biopharmaceutical industry with Bachelor's Degree, or 4 years with Master's degree.
• Strong preference for experience in Cell/Gene Therapy, Cell-Based Assays, and Rapid Microbial Methods.
• Expertise in SOPs, analytical test methods, and laboratory practices.
• Knowledge of USP/EP/cGMP and ICH guidelines, microbiology techniques, and LIMS.