31 Jul
|
University Of Cambridge
|
Secunderabad
31 Jul
University Of Cambridge
Secunderabad
PopVax is looking for an experienced Microbiologist to join our Quality Control (QC) team to support microbial testing and ensure the highest standards of quality in our vaccine development process. The ideal candidate will have substantial experience in microbiology testing in a cGMP (current Good Manufacturing Practices) environment, with a focus on vaccines and biotechnological products. You will be responsible for microbial testing, cell banking, sterility testing, and supporting overall QC activities, ensuring compliance with regulatory standards.
Key Responsibilities:
- Perform microbiology testing for Quality Control (QC) in a cGMP environment, with a focus on vaccines and biopharmaceuticals.
- Prepare and maintain master and working cell banks, and characterize microbial and mammalian cell lines.
- Perform 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, de-contamination, 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 (e.g., finger-dabbing).
- 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.
Qualifications:
- 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.
What We Offer:
- Competitive compensation package.
- Comprehensive health insurance covering immediate family (including pre-existing conditions).
- A collaborative work environment focused on solving cutting-edge challenges in mRNA vaccine development.
- Opportunities for growth and career 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.
📌 Executive/Senior Executive Microbiology QC (Secunderabad)
🏢 University Of Cambridge
📍 Secunderabad