Microbiologist Specialist

NALIS PHARMACEUTICALS is seeking a highly skilled and experienced Microbiologist Specialist to join our team. As a key member of our laboratory staff, you will play a vital role in ensuring the quality and safety of our pharmaceutical products.

Job Description:

The successful candidate will be responsible for conducting microbiological tests and analyses to ensure compliance with regulatory standards. This will involve investigating microbial contamination, developing new methodologies, and optimizing existing testing methods.

Key Responsibilities:

• Perform microbiological tests on raw materials, in-process materials, and finished products to detect microbial contamination and ensure compliance with established specifications.
• Develop, validate, and optimize microbiological testing methods in accordance with regulatory requirements (e.g., FDA, EMA).
• Analyze test results and interpret data to provide insights on microbial quality and safety, preparing comprehensive reports for internal and external stakeholders.
• Investigate sources of microbial contamination and develop strategies for contamination control to improve manufacturing processes and product quality.
• Conduct environmental monitoring in controlled areas (e.g., cleanrooms) to ensure compliance with environmental standards and regulations.
• Collaborate with the Quality Assurance team to ensure that microbiological testing aligns with Good Manufacturing Practices (GMP) and other regulatory standards.
• Participate in research and development projects aimed at improving product formulations and enhancing microbial stability.
• Provide training and guidance to laboratory personnel on microbiological techniques, safety protocols, and best practices.
• Maintain accurate and detailed records of all testing activities, procedures, and results in compliance with laboratory protocols and regulatory requirements.
• Stay current with industry trends, advancements in microbiology, and regulatory changes to contribute to the continuous improvement of laboratory processes and procedures.

Qualifications:

• Bachelor's degree in Microbiology, Biology, or a related field (Master's degree preferred).
• Minimum of 2 years of experience in microbiological testing, preferably in a pharmaceutical or biotechnology setting.
• 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.

Estimated Salary: $80,000 - $110,000 per year.

NALIS Pharmaceuticals offers:

• A competitive salary package.
• Ongoing training and professional development opportunities.
• A dynamic and supportive work environment.
• The opportunity to work with a leading pharmaceutical company.