Director of Microbiology

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 the 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, 3900 Duckhorn Dr, Sacramento, CA 95834.

About the role

The Director of Microbiology is responsible for leading the microbiology function within the organization, ensuring the highest standards of sterility, regulatory compliance, environmental monitoring, and scientific excellence. This role oversees microbiological testing, contamination control, regulatory alignment, team leadership, and continuous improvement in sterile pharmaceutical manufacturing.

Responsibilities

Quality Control & Sterility Assurance

• Establish and maintain stringent microbiological quality control measures.
• Develop protocols for microbial testing, validation, and monitoring to ensure sterile conditions.
• Ensure all products meet contamination-free standards and comply with regulatory expectations.
• Oversee validation of microbial methods, equipment, and aseptic processes.
• Ensure compliance with GMP and other applicable regulatory frameworks.
• Conduct routine audits and inspections to verify adherence to microbiological standards.
• Investigate and resolve microbiological deviations or contamination events.

Regulatory Compliance & Documentation

• Stay current with evolving guidelines from FDA, EMA, WHO, and other agencies.
• Ensure all microbiological testing, reporting, and documentation meet regulatory requirements.
• Prepare and submit documentation for regulatory approvals, audits, and inspections.
• Collaborate with regulatory authorities during audits and inspections.
• Implement regulatory changes into microbiological practices and SOPs.

Environmental Monitoring & Contamination Control

• Design and implement environmental monitoring programs for cleanrooms and controlled areas.
• Analyze environmental data to identify trends, risks, and contamination sources.
• Ensure timely reporting, escalation, and remediation of microbial contamination.
• Develop contamination prevention strategies, including aseptic technique training.
• Collaborate with facilities management to maintain cleanliness and controlled environments.

Team Leadership & Development

• Lead, mentor, and develop microbiologists and technicians.
• Recruit, train, and onboard new microbiology staff.
• Set performance goals and conduct regular evaluations.
• Foster a collaborative, innovative, and scientifically rigorous work culture.
• Provide technical guidance and support to the team.
• Allocate resources effectively to meet departmental and project objectives.

Innovation, Research & Cross‑Functional Collaboration

• Collaborate with R&D to develop new microbiological methods and technologies.
• Evaluate and implement advanced microbial detection and identification techniques.
• Participate in clinical trials, product development, and method development projects.
• Stay informed about emerging trends in microbiology and sterile pharmaceutical manufacturing.
• Contribute to scientific publications, conferences, and knowledge‑sharing initiatives.

Requirements

• Degree: Bachelor's degree in Microbiology, Biology, or related life sciences; an MS or PhD is strongly preferred for leadership roles.
• Experience: 10 to 14+ years of relevant experience in a cGMP regulated pharmaceutical, biotech, or sterile manufacturing environment.
• 10 to 15+ years of progressive laboratory, sterility assurance, or quality control experience.
• Leadership: Proven track record of managing large teams, departmental budgets, and cross-functional or global matrix organizations.
• Must have experience in Pharmaceutical Manufacturing.
• Valid driver's license and acceptable driving record.
• Legally authorized to be employed in the United States.
• Must live or be willing to move to the Sacramento Metropolitan Region (approx. 40 miles' radius).

Physical Requirements / Working Conditions

• Work is performed in a GMP pharmaceutical manufacturing facility, including offices, inspection areas, packaging suites, warehouse areas, controlled production spaces, and support areas.
• The role may require work near visual inspection equipment, packaging lines, labelers, serialization systems, carts, conveyors, printed materials, and finished goods.
• Strict adherence to GMP, safety, documentation, label control, material control, and reconciliation procedures is required.
• Standard business hours are typical; off-shift support may be required based on production needs.
• Overtime, weekends, holidays, shutdown coverage, campaign support, and urgent issue response may be required.
• Must be able to support manufacturing campaigns, validation activities, inspections, and critical batch operations.

Schedule / Shift Requirements

• Standard business hours are typical, but support outside normal hours is required based on production, project, shutdown, or emergency needs.
• Overtime, weekends, holidays, shutdown coverage, and on-call availability may be required.
• Must be able to respond to urgent equipment, facility, utility, automation, quality, and supply-continuity issues.

Benefits

• Competitive Salary: Based on experience.
• Yearly bonus eligibility.
• Medical, dental, and vision coverage.
• Sick time/PTO.