Microbiologist Full-time

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. At Nivagen, 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
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. Your expertise will directly contribute to Quality and affordable medication.
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.
Joining Nivagen as a Microbiologist means being part of a visionary team dedicated to expanding access to quality, affordable medication. If you are passionate about quality, service, and innovation, and are eager to make a difference in people's lives, we invite you to bring your expertise and enthusiasm to our dynamic team.
Conducts microbiological testing of primary packaging materials, raw materials, in process sample, finished products, and environmental samples using various techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing.
Develops and validates microbiological test methods in accordance with compendial and regulatory requirements.
Maintains accurate and detailed records of all microbiological testing and analysis performed. Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures. Microbiology-related projects, including method transfers, validations, and investigations.
Collaborates with cross-functional teams to achieve project objectives and timelines.
Provides training and mentorship to microbiology staff.
Shares knowledge and expertise to promote continuous learning and development within the microbiology team.
Identifies opportunities for process improvements and optimization within the microbiology laboratory.
Performs a variety of Microbiology testing to assess the strength, identity, and purity of test samples and/or materials.
Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. Personal protective equipment and Respirators are essential for the health and safety of employees. Position requires working in the laboratory as well as sitting Microbiological method development and method validation procedures like BET, Sterility, MLT, Bio Assay and Disinfectant qualification and microbiological hold time validation, Container closure integrity validation.
Strong knowledge of microbiological testing techniques, methods, and equipment.

Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
Builds partnerships and works collaboratively with others to meet shared objectives.
Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
Adapts approach and demeanor in real time to match shifting demands of different situations.
We believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth. By prioritizing the well-being and development of our employees, we create an environment where everyone can thrive and contribute their best.
Quality: Quality stands at the core of our mission. We adhere to the highest standards of quality control and continuously strive to improve our processes to ensure that our products meet the needs of those we serve. Our dedication to quality is unwavering and is evident in every aspect of our work.
Service: Every interaction with our patients, providers, employees, and other stakeholders comes from a place of service. We are committed to delivering exceptional service and ensuring that every experience with our company is positive and impactful. Our service-oriented approach helps us build strong, lasting relationships and fulfill our mission of improving healthcare outcomes.
Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care. Innovation drives us to find better ways to serve our patients, improve our products, and streamline our operations. In summary, our core values—People, Quality, Service, and Innovation—are integral to everything we do. Bachelor's degree in microbiology, Biology, or related field required; Minimum of 3 years of experience in a microbiology laboratory required.
Previous experience in a pharmaceutical or compounding environment preferred.
Experience with compendia testing: United States Pharmacopeia, and regulatory requirements (Food and Drug Administration and cGMP) preferred.
Experience with microbiological method development and method validation procedures like Sterility Testing, Endotoxin Testing, Disinfectant Efficacy Study, Water Testing, Method Validation, Environment Monitoring, Microbial Limit Testing, PET, and microbiological hold time validation, container closure integrity.
Yearly bonus eligibility

• Medical, dental and vision coverage
• Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.