Senior Microbiologist Position

PopVax seeks an experienced Microbiologist to support microbial testing and ensure the highest standards of quality in vaccine development.

Key Responsibilities:

• Perform microbiology testing for Quality Control (QC) in a cGMP environment, focusing on vaccines and biopharmaceuticals.
• Prepare and maintain master and working cell banks, characterizing microbial and mammalian cell lines.
• Conduct routine cell passaging, viability testing, staining techniques, cell counting, and sub-culture activities.
• Oversee media preparation, sterility testing, environmental monitoring (EMP), and personnel monitoring to ensure sterile conditions and high standards.
• Conduct microbial testing of water samples and in-process samples, including preservative efficacy studies and disinfectant validation.
• Operate and validate laboratory instruments such as autoclaves, microscopes, cell counters, and particle counters.
• Identify and analyze a wide spectrum of bio-contaminants, including bacteria and fungi, using various microbiological techniques.
• Manage biowaste, decontamination, cleaning processes, and ensure compliance with local laws and regulations.
• Plan and execute comprehensive sample collection for environmental monitoring, including water collection, area swabs, and personal monitoring.
• Manage data from microbiological testing, track trends, and report results accurately and comprehensively.
• Ensure operational and GMP readiness of QC areas, maintaining the highest standards of cleanliness and quality.
• Coordinate with outsourced testing providers, ensuring proper documentation and meeting all quality assurance requirements.
• Investigate out-of-specification (OOS), out-of-limits (OOL), and out-of-trend (OOT) incidents, identifying corrective actions.
• Develop and maintain SOPs for QC testing, following both compendial and non-compendial methods, and train team members on these procedures.
• Participate in regulatory audits, ensuring compliance with CDSCO/DCGI, WHO, and US FDA guidelines and standards.
• Handle change controls, deviations, incident investigations, and ensure proper documentation for quality management systems.

• MSc in Microbiology or related life sciences field.
• At least 4+ years of experience in microbiology testing in a cGMP environment, with a preference for vaccine-related experience.
• Proficiency in cell banking, cell line characterization, and sterile technique, including cell passaging, viability testing, and sub-culturing.
• Strong knowledge of media preparation, sterility testing, environmental monitoring, and microbial testing for water and in-process samples.
• Familiarity with disinfectant validation, preservative efficacy studies, and understanding of bio-contaminant identification.
• Experience with autoclaves, microscopes, cell counters, particle counters, and other lab instruments.
• In-depth understanding of global guidelines on analytical method validation and 21 CFR Part 11 compliance for microbiology testing.
• Experience with regulatory audits, particularly from CDSCO/DCGI, WHO, or US FDA.
• Strong analytical skills, with the ability to track, analyze, and report QC data.
• Demonstrated ability to work independently and handle a variety of testing procedures with minimal supervision.
• Exceptional oral and written communication skills.
• Ability to work shifts, including night shifts, based on project requirements.

• Competitive compensation package.
• Comprehensive health insurance covering immediate family.
• A collaborative work environment focused on solving cutting-edge challenges in mRNA vaccine development.
• Opportunities for growth and professional development in a fast-paced, innovative company.
• The chance to contribute to high-impact work with the potential to make a global difference in public health.