Microbiologist II

American Regent Inc. is a prominent pharmaceutical company dedicated to advancing health care by developing and manufacturing innovative pharmaceutical and biotechnology products. Recognized for its commitment to quality and research, American Regent provides a range of therapeutic solutions to meet critical medical needs globally. The company fosters a culture of inclusivity and equal opportunity, ensuring a diverse workforce where all employees are valued and supported. Through its robust manufacturing capabilities and adherence to the highest industry standards such as FDA regulations and cGMP/cGLP practices, American Regent upholds excellence in its operational processes.

The Quality Control Microbiologist role at American Regent is critical to supporting manufacturing activities by ensuring the highest quality and safety standards of pharmaceutical products. This position involves rigorous testing of raw materials, in-process samples, and finished goods for microbial contamination, endotoxins, and other quality parameters within cleanroom environments. The incumbent will be responsible for performing bioburden and endotoxin testing, including microbial enumeration, endotoxin quantification, Gram staining, and growth promotion tests. Additionally, the role supports environmental monitoring in classified cleanrooms (Grade C & D) to detect microbial and particulate contamination and safeguard aseptic processing standards.

The role requires collaboration with both internal teams and external third-party testing laboratories to maintain compliant and precise quality control measures. Responsibilities extend to ordering and managing laboratory supplies, optimizing and validating microbiological test methods, and preparing comprehensive documentation such as protocols, data reports, and standard operating procedures. Employees will participate in validation activities pertaining to autoclave functions, sterilization in place, and vaporized hydrogen peroxide sterilization, helping to maintain aseptic process integrity.

The position demands strict compliance with FDA regulations and internal policies to meet cGMP and cGLP requirements and emphasizes meticulous documentation and quality assurance. The Quality Control Microbiologist will provide essential support for manufacturing operations via aseptic process simulations, retention studies, and verification of container closure integrity and sterilization cycles. Ongoing training, data trending, and proactive management of quality data are fundamental to ensure product compliance and continuous improvement.

Situated in a cleanroom environment, this role requires physical readiness to wear protective gowning and personal protective equipment including respirators, goggles, and gloves while meeting specific vision requirements and maintaining a clean-shaven face to properly use tight-fitting respirators. The salary range for this position is between $79,000 and $84,000 annually, supplemented by a competitive total rewards package that includes healthcare, life insurance, profit sharing, paid time off, and a 401k matching plan. American Regent stands out as a supportive and forward-thinking employer, dedicated to professional development, operational excellence, and diversity inclusion in the pharmaceutical industry.