ScaleUp Bio is seeking a technically competent Microbiologist to support Microbiological testing, Environmental monitoring, contamination control, and Laboratory operations.
The role is responsible for ensuring microbiological quality and compliance across raw materials, manufacturing processes, utilities, controlled environments, In-process and finished products.
The ideal candidate is hands-on, quality-focused, and capable of working effectively within a multidisciplinary team, supporting biotechnology and fermentation-based manufacturing operations. This individual should be comfortable operating in a manufacturing area while maintaining high standards of laboratory discipline, and regulatory compliance.
Key Responsibilities
Microbiological Testing
Prepare and maintain working cell banks, vials.
Perform routine microbiological testing of raw materials, in-process samples, finished products, utilities (water, compressed air, and steam), and environmental monitoring samples.
Conduct microbial limit testing, bioburden testing, sterility testing, and other microbiological analyses as required.
Perform microbial identification using conventional and rapid microbiological methods.
Prepare, qualify, and maintain microbiological media, reagents, standards, and laboratory supplies.
Review and verify microbiological test results for accuracy, completeness, and compliance.
Environmental Monitoring
Execute environmental monitoring programs for cleanrooms and controlled manufacturing area.
Collect, analyse, and document air, surface, personnel, water, and utility monitoring samples.
Trend environmental monitoring data and identify potential contamination risks and adverse trends.
Support investigations related to environmental monitoring excursions, out-of-limit results, and contamination events.
Contribute to contamination control strategies and continuous monitoring improvements.
Quality & Compliance
Ensure all laboratory activities comply with GMP, GLP, data integrity requirements and SOP’s.
Review & maintain laboratory reports, test results, logs, worksheets, and documentation.
Participate in deviation investigations, root cause analysis, CAPA implementation, change controls, and RA.
Support internal audits, customer audits, supplier audits, and regulatory inspections.
Laboratory Operations & Equipment Management
Operate, maintain, and perform routine checks on microbiological laboratory equipment, which includes: Biosafety Cabinets, Shaker Incubators, Autoclaves, Deep Freezers, Incubators, Colony Counters, Analytical Balances, Spectrophotometers, Moisture Analyser, HPLC, 10L glass reactor and other analytical instruments, as required
Support equipment qualification, calibration coordination, preventive maintenance, and troubleshooting activities.
Operate and monitor 10 L glass reactor systems for pilot-scale fermentation, microbial cultivation, ensuring compliance with established procedures and safety requirements.
Assist in method validation, verification, and technology transfer activities.
Monitor laboratory inventory and coordinate procurement of microbiological consumables and reagents.
Maintain laboratory cleanliness, organization, and biosafety standards.
Technical Support & Continuous Improvement
Provide microbiological expertise to Manufacturing, Quality Assurance, Process Development, and Pilot Scale Manufacturing teams.
Support contamination investigations and root cause analyses for microbiological events.
Assist in developing, reviewing, and revising SOPs, protocols, specifications, and technical reports.
Support process optimization and continuous improvement initiatives related to microbiology and contamination control.
Contribute to the implementation of new microbiological technologies and laboratory best practices.
Requirements
Diploma/Bachelor's Degree in Microbiology / Biotechnology / Life Sciences, or a related discipline.
Minimum 3 - 5 years of relevant microbiology laboratory experience.
Experience in food manufacturing, fermentation, life sciences, biotechnology, pharmaceuticals, or related industries preferred.
Strong knowledge of microbiological testing techniques, aseptic practices.
Able to work independently with GMP, GLP, data integrity requirements, and quality management systems.
Experience with environmental monitoring programs and cleanroom operations is advantageous.
Strong documentation, organizational, and communication skills.
Ability to work independently and collaboratively in a fast-paced environment.
Flexible to work weekends, shifts, or overtime as required by operational needs.
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