Laboratory Microbiologist for Pharmaceutical Research and Development
2 weeks ago
We are seeking a highly skilled Laboratory Microbiologist to join our team at Nalis Pharmaceuticals. As a key member of our research and development department, you will be responsible for conducting microbiological tests and analyses to ensure the safety, quality, and efficacy of our pharmaceutical products.
Job DescriptionIn this role, you will perform microbiological tests on raw materials, in-process materials, and finished products to detect microbial contamination and ensure compliance with established specifications. You will also develop, validate, and optimize microbiological testing methods in accordance with regulatory requirements (e.g., FDA, EMA).
You will analyze test results and interpret data to provide insights on microbial quality and safety, preparing comprehensive reports for internal and external stakeholders. Additionally, you will investigate sources of microbial contamination and develop strategies for contamination control to improve manufacturing processes and product quality.
Other responsibilities include conducting environmental monitoring in controlled areas (e.g., cleanrooms) to ensure compliance with environmental standards and regulations, collaborating with the Quality Assurance team to ensure that microbiological testing aligns with Good Manufacturing Practices (GMP) and other regulatory standards, and participating in research and development projects aimed at improving product formulations and enhancing microbial stability.
As a Laboratory Microbiologist, you will also provide training and guidance to laboratory personnel on microbiological techniques, safety protocols, and best practices. You will maintain accurate and detailed records of all testing activities, procedures, and results in compliance with laboratory protocols and regulatory requirements.
QualificationsTo be successful in this role, you will require a Bachelor's degree in Microbiology, Biology, or a related field (Master's degree preferred). A minimum of 2 years of experience in microbiological testing, preferably in a pharmaceutical or biotechnology setting, is also essential.
You should have a strong understanding of microbiological techniques, aseptic practices, and regulatory requirements governing microbiological testing. Excellent analytical and problem-solving skills, attention to detail, and proficiency in laboratory software and data analysis tools are also required.
Physical RequirementsThe ability to work in a laboratory environment, including the ability to lift and carry materials and stand for extended periods, is necessary for this role.
Estimated Salary$85,000 - $110,000 per year.
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