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.
Key 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.
Minimum Requirements:
Bachelor of Science degree in a scientific discipline with a minimum of 5 years of technical experience, including 3 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.
Authorization to work for any employer in the U.S.
