Microbiologist

About the Company

Nivagen is a global company dedicated to enhancing lives by developing and providing cost‑effective generic prescription drugs and over‑the‑counter products for the North American market. For over a decade, we have remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.

Through vertical integration of the pharmaceutical supply chain, cutting‑edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well‑being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry.

Our mission is clear: to make a meaningful difference in people’s lives by delivering high‑quality, affordable medications while upholding the highest standards of integrity and excellence.

Nivagen Pharmaceuticals, Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834

Title of the Position:
Microbiologist (Full Time)

At Nivagen as a Microbiologist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real‑time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements.

As a Microbiologist you will play a critical role in the success of our operations. This position is integral to our commitment to excellence, as it involves developing and validating microbiological test methods, maintaining detailed records, and preparing reports, protocols, and standard operating procedures (SOPs). Your expertise will directly contribute to quality and affordable medication.

Collaboration is key in this role. You will work closely with cross‑functional teams to meet project objectives and timelines and identify opportunities for process improvements. Your proactive approach and innovative mindset will help us enhance efficiency and effectiveness within our microbiology laboratory and reinforce our dedication to quality and compliance.

Additionally, in this influential role you will be a mentor, providing training and guidance to microbiology staff, fostering an environment of continuous learning and professional growth.

• Conduct microbiological testing of primary packaging materials, raw materials, in‑process samples, finished products, and environmental samples using various techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing.
• Develop and validate microbiological test methods in accordance with compendial and regulatory requirements.
• Maintain accurate and detailed records of all microbiological testing and analysis performed. Prepare and review reports, protocols, and SOPs related to microbiological activities.
• Ensure compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures. Participate in internal and external audits as needed.
• Lead microbiology‑related projects, including method transfers, validations, and investigations.
• Collaborate with cross‑functional teams to achieve project objectives and timelines.
• Provide training and mentorship to microbiology staff.
• Share knowledge and expertise to promote continuous learning and development within the microbiology team.
• Identify opportunities for process improvements and optimization within the microbiology laboratory.
• Implement best practices and innovative solutions to enhance efficiency and effectiveness.
• Perform a variety of microbiology testing to assess the strength, identity, and purity of test samples and/or materials.
• Perfo…