EM Microbiologist

About the role

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.

Responsibilities

• 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.
• Prepares and reviews reports, protocols, and SOPs related to microbiological activities.
• Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures.
• Participates in internal and external audits as needed.
• Collaborates with cross-functional teams to achieve project objectives and timelines.
• Provides training and mentorship to microbiology staff.
• Identifies opportunities for process improvements and optimization within the microbiology laboratory.
• Implements best practices and innovative solutions to enhance efficiency and effectiveness.

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.

Skills

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

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
401k savings plan