EM Microbiologist

Job Location Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job 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. 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 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. 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. Perform other duties as assigned. Physical Demands 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. 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. 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. 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 $70,000 - 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 401(k) savings plan Additional Information Nivagen affords 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. #J-18808-Ljbffr Nivagenpharmaceuticals