General Manager/ Plant Head - Sterile

About the Company:

Nivagen is a global company devoted to improving lives by developing high-quality, affordable generic prescription drugs and over-the-counter products for the North American market. For over a decade, we have remained committed to our core values of excellence, integrity, and respect for people. Our dedicated team works collaboratively to advance manufacturing, distribution, and quality control, taking a comprehensive approach to healthcare. Through vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and an unwavering focus on excellence, we continually strive to enhance access to and affordability of medications.

We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and strong training and development programs. By investing in our workforce and nurturing a culture of growth and support, we empower our team to drive innovation and make a positive impact in healthcare. Our mission at Nivagen is clear: to improve lives by providing high-quality, affordable medications while upholding the highest standards of integrity and excellence.

As a leader in pharmaceutical manufacturing, Nivagen is committed to producing sterile products that meet the healthcare industry’s rigorous demands. Specializing in the production of vials, pre-filled syringes (PFS), and IV bags, we aim to make a meaningful impact on patient care. Join our team to help push the boundaries of sterile manufacturing and achieve the highest standards in safety, quality, and operational efficiency.

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: General Manager / Plant Head - Sterile  (Vials, PFS & IV Bags)

Reports to: CEO

We are looking for a seasoned and motivated General Manager / Plant Head to lead our sterile operations for vials, pre-filled syringes, and IV bags. The General Manager (GM) is responsible for the overall leadership, strategic direction, and operational excellence of a sterile injectable and 503B outsourcing facility. This role has full accountability for safety, quality, regulatory compliance, financial performance, and operational execution, ensuring the facility consistently meets business objectives, regulatory requirements, and customer expectations. The GM serves as the site leader and primary interface with corporate leadership, regulatory agencies, and key external partners, including the FDA and the DEA, as applicable.

Key Responsibilities:

Strategic & Business Leadership

• Provide overall leadership and direction for the sterile injectable manufacturing site, aligning site objectives with corporate strategy.
• Develop and execute short- and long-term operating plans, including capacity planning, capital investments, and continuous improvement initiatives.
• Own site-level P&L responsibility, including budgeting, forecasting, cost control, and financial performance (as applicable).
• Support business development activities, including customer audits, technical evaluations, commercialization readiness, and 503B customer engagement.

Operations & Manufacturing

• Oversee all sterile manufacturing operations, including aseptic processing, formulation, filling, large-volume parenterals (LVPs) and sterile IV bag manufacturing, small-volume parenterals (vials, PFS, cartridges), inspection, packaging, and warehousing.
• Provide leadership for operations involving DEA-controlled substances, ensuring compliant handling, secure storage, inventory reconciliation, and chain-of-custody controls.
• Ensure efficient production scheduling, resource utilization, and timely delivery while maintaining the highest quality standards.
• Drive operational excellence through Lean, Six Sigma, and other continuous improvement methodologies.
• Lead technology transfer, scale-up, validation, and commercial manufacturing activities, including those supporting 503B compounded sterile preparations.

Quality & Regulatory Compliance

• Ensure full compliance with cGMP, FDA, and board of pharmacy (503B) regulatory requirements, as well as applicable global standards where relevant.
• Ensure compliance with DEA regulations, including facility registration, security systems, recordkeeping, reporting, and inspection readiness (as applicable).
• Foster a strong quality culture with clear accountability across manufacturing, quality assurance, and quality control functions.
• Act as the primary site representative during FDA, DEA, board of pharmacy, customer audits, and third-party assessments.