For this role you will be responsible for supporting microbiological programs and testing activities for processes, instruments, and equipment while ensuring optimal resource utilization and high-quality product and process development. The individual in this position will oversee various programs under management's direction, including Clean Utility Monitoring, Product Testing, Media Release, Laboratory Support, and other responsibilities.
- Oversee Clean Utility Monitoring( Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates, USP testing, AET,), Product Testing, Media Release, Laboratory Support, and other assigned programs as directed by management.
- Manage and develop laboratory staff, including scheduling, training, performance reviews, and goal setting.
- Execute and review routine Microbial Laboratory work, make detailed observations, and conduct advanced data analysis. Ensure method verifications, qualification protocols, and investigations are conducted appropriately.
- Maintain familiarity with current regulations and scientific literature, ensuring adherence to GMPs and biotechnology-derived product regulations.
- Ensure proper handling, labeling, and storage of chemical and biohazard materials. Adhere to safety requirements and hazardous waste management protocols.
- Demonstrate a strong orientation for quality and customer service, contributing to science in the appropriate area.
- Bachelor of Science degree in a scientific discipline with a minimum of 5 years of technical experience, including 2 years of managerial experience.
- Knowledge of GMPs and biotechnology-derived product regulations. Strong commitment to quality and customer service, with a demonstrated track record in the relevant field. Integrity, personal responsibility, and respect for individuals.
- Proficiency in managing laboratory operations in accordance with pharmaceutical regulations.