Nivagen Pharmaceuticals, Inc. · 16 hours ago
General Manager/ Plant Head - Sterile
Sacramento, CA 95834
Full-time
Onsite
Director/Executive
10+ years expNivagen Pharmaceuticals is a global company committed to improving lives by developing high-quality, affordable generic medications. They are seeking a General Manager/ Plant Head to lead their sterile operations, overseeing all aspects of manufacturing, quality compliance, and operational excellence for sterile injectables.
ManufacturingMarket ResearchPharmaceutical
Responsibilities
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
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
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
Ensure robust deviation management, CAPA execution, change control, and data integrity practices
Promote and enforce a strong safety culture, ensuring compliance with all environmental, health, and safety regulations
Ensure safe operation of aseptic facilities, including cleanrooms, hazardous materials, controlled substances, and high-risk operations
Build, develop, and retain a high-performing leadership team across operations, quality, engineering, supply chain, and support functions
Set clear performance expectations and drive accountability at all levels of the organization
Lead workforce planning, training, and succession planning to support current and future operational needs, including 503B compliance training
Foster a culture of collaboration, continuous learning, quality, and operational discipline
Oversee facilities, utilities, and engineering functions, including cleanroom systems, HVAC, WFI, clean steam, automation, and security systems required for DEA compliance
Lead capital projects, facility expansions, equipment procurement, and maintenance programs
Ensure facility readiness for regulatory inspections, audits, and sustained commercial operations
Qualification
Required
Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry or a related field
Minimum of 10–15 years of progressive leadership experience in pharmaceutical manufacturing, with significant experience in sterile injectable/aseptic manufacturing
Proven track record of leading GMP-regulated manufacturing or 503B outsourcing facilities, preferably as a site head or senior operations leader
Hands-on experience with FDA inspections and customer audits
Experience handling DEA-controlled substances in a registered facility
Strong understanding of aseptic processing, contamination control, and sterile manufacturing technologies
Working knowledge of 503B regulatory requirements and risk-based quality systems
Demonstrated financial acumen and operational decision-making capability
Excellent leadership, communication, and stakeholder management skills
Ability to balance strategic vision with hands-on operational execution
Strong problem-solving skills with a data-driven and risk-based mindset
Must live or be willing to move to the Sacramento Metropolitan Region (Approx 40 miles' radius)
Preferred
An advanced degree is a plus
DEA inspection experience is a strong plus
Experience with large and Small-volume parenterals manufacturing and associated processes
Experience in CDMO environments, startup facilities, or turnaround situations
Knowledge of DEA compliance, including security, inventory controls, reconciliation, and reporting
Benefits
Medical, dental, and vision coverage
Paid time off plan
401k savings plan
Company
Nivagen Pharmaceuticals, Inc.
Nivagen is engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market.
11-50 employees
H1B Sponsorship
Nivagen Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (19)
2023 (15)
2022 (5)
2021 (11)
2020 (7)
Funding
Current Stage
Early StageTotal Funding
$31MKey Investors
Telegraph Hill Partners
2026-01-06Acquired
2023-08-09Series Unknown· $5M
2020-05-19Series Unknown· $16M
Recent News
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2026-01-07
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