General Manager/ Plant Head - Sterile na Nivagen Pharmaceuticals

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.
• Ensure robust deviation management, CAPA execution, change control, and data integrity practices.

Safety, Health & Environment (EHS)

• 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.

People & Organizational Leadership

• 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.

Engineering & Facilities

• 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.

Qualifications:

Education/Experience:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry or a related field. An advanced degree is a plus.

• 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; DEA inspection experience is a strong plus.

   

• Experience handling DEA-controlled substances in a registered facility is preferred.

   

• Experience with large and Small-volume parenterals manufacturing and associated processes is preferred.

   

• Experience in CDMO environments, startup facilities, or turnaround situations is a plus

Knowledge, Skills, and Abilities:

• Strong understanding of aseptic processing, contamination control, and sterile manufacturing technologies.

   

• Working knowledge of 503B regulatory requirements and risk-based quality systems.

   

• Knowledge of DEA compliance, including security, inventory controls, reconciliation, and reporting (preferred).

   

• 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.

 Requirements:

• Must live or be willing to move to the Sacramento Metropolitan Region (Approx 40 miles’ radius)

Benefits:

• Pay range: Competitive Salary
• 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

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.