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.

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

• 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.
• Participate in internal and external audits as needed.
• 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 a variety of Microbiology testing to assess the strength, identity, and purity of test samples and/or materials.
• Performs other duties as assigned.

Knowledge and Skills

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

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 $80,000-$85,000 per Year
• Yearly bonus eligibility
• Benefits: Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan