#x 9; 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. O... more details
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.
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