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've 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. 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.

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: EM Microbiologist  Swing Shift ONLY (3 PM - 12 AM)

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.

Position Summary

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.

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.

Duties and Responsibilities

• Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures. Participate in internal and external audits as needed
• Conducts routine and non-routine environmental monitoring activities in classified cleanrooms, including non-viable, viable, contact, and swab surface sampling.
• Performs environmental monitoring during aseptic filling production, requiring strict adherence to aseptic behaviors and cleanroom gowning in Grade A and Grade B (ISO 5 and 6) production environments.
• Conducts microbiological sampling of various utilities, including portable water, purified water, water for injection, pure steam, compressed gas, and nitrogen.
• Maintains accurate and detailed records of all microbiological testing and analysis performed, utilizing high standards and adhering to strict requirements of good documentation practices (cGDP).
• Prepares and reviews reports, protocols, and SOPs related to microbiological activities.
• Participates in 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.
• Implements best practices and innovative solutions to enhance efficiency and effectiveness.
• Performs other duties as assigned.
• While performing the responsibilities of the job, the employee is required to talk and hear. Must be able to bend at the waist and knees as well as twist at the trunk. Must be able to lift up to 25 lbs. 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

Knowledge and Skills

• Strong knowledge of microbiological testing techniques, methods, and equipment.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

People: Our people define who we are as a company. 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. It reflects our commitment to excellence in every medication we produce. 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: We are here to serve others. 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. We are committed to staying ahead of industry trends and leveraging cutting-edge technology to enhance the value we provide.

In summary, our core values—People, Quality, Service, and Innovation—are integral to everything we do. They guide our actions, shape our culture, and inspire us to achieve excellence in all our endeavors. By staying true to these values, we ensure that we fulfill our mission and make a positive impact on the lives of those we serve.

Experience and Qualifications

• Bachelor’s degree in microbiology, Biology, or related field required; Master's degree preferred.
• 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.

Benefits:

• Pay range $75,000 - 85,000 per Year
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental and vision coverage
• Paid time off plan

Additional Information:

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.

We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.