Sr. Microbiologist

Summary:

The Senior Microbiologist is responsible for performing the required microbiological testing of compounded sterile preparations (CSP) in accordance with established procedures. This position is the SME for microbiological methods performed at our Petaluma, CA laboratory which includes technical advising for clients on advanced method development using a range of microbiology instrumentation. Candidates will also perform standard testing of samples using various methods and instruments while analyzing test results and assisting in troubleshooting testing.

Essential Duties/ Responsibilities:

• Work as a SME for various microbiological methods performed in the facility.
• Function as a technical leader to assist/advise clients in developing new methods using novel instruments in the microbiological field.
• Develop and implement microbiology testing methods, analyze data, and provide actionable insights.
• Perform routine laboratory tasks including sample logging, testing, trend analysis, and environmental monitoring.
• Maintain stock cultures, biological indicators, and high-quality microbiological media.
• Conduct sterilization testing and microbiological research as needed.
• Ensure compliance with ISO or/and USP/EP chapters for various microbiological assessments.
• Qualify, calibrate, and maintain all equipment to meet "Before-Use" standards.
• Adhere to Good Documentation Practices and prepare GMP documentation.
• Provide expert guidance to clients on microbiology processes, products, and risks.
• Coach and mentor internal stakeholders to ensure ISO/GMP compliance.
• Support cleanroom qualification, requalification, and environmental monitoring.
• Maintain a pristine and well-equipped microbiology laboratory environment.
• Participate in regulatory affairs, investigations, audits, and inquiries to uphold high standards.
• Plans, schedules, and arranges own and others' activities in accomplishing objectives.

Qualifications:

• Bachelors degree in microbiology, or a related field from an accredited college or university. 5 years of experience in Microbiology Testing within an industry laboratory environment/setting.
• Masters degree in a related area and three years of directly relevant experience may be substituted for the bachelors degree and experience.
• PhD in a related area and one year of directly relevant experience may be substituted for bachelors degree and experience.

Competencies:

• Highly efficient, accustomed to problem-solving and multitasking in a deadline-driven environment.
• Assumes responsibility for the accuracy and timeliness of the completed work.
• Typically assigned difficult, demanding, or complex tasks, which may require independent action and a high degree of initiative.
• Assist with establishing and maintaining safe work standards in the Lab.
• Complete understanding and application of principles, concepts, practices, and standards, including GMP/ISO/USP standards.
• Efficient use of laboratory equipment including, microscopes, velometer, balance, autoclave, water purification system, hood operation, particulate counter, membrane filtration, endotoxin plate reader, etc.
• Standard office equipment including computers, copiers, and scanners.
• Frequently requires the use of potentially hazardous chemicals and reagents.
• Must be able to lift up to 30 pounds.

Infinity Laboratories is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.