Manufacturing Head - Sterile Manufacturing; Vials, PFS & IV Bags

Manufacturing Head - Sterile Manufacturing (Vials, PFS & IV Bags)

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 medication accessibility and affordability.

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, achieving the highest standards in safety, quality, and operational efficiency.

Job Location:

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position
:
Manufacturing Head - Sterile Manufacturing (Vials, PFS & IV Bags)

Department: Manufacturing Operations

Reports to: CEO

We are looking for a seasoned and motivated Manufacturing Head to lead our sterile production operations for vials, pre-filled syringes, and IV bags. This key role is essential in ensuring that our manufacturing processes not only comply with regulatory standards but also consistently meet production goals and exceed quality benchmarks. The Manufacturing Head will manage a skilled team, champion continuous improvement initiatives, and play a vital role in advancing operational excellence and product quality.

Responsibilities:

• Lead and manage sterile manufacturing processes, overseeing production for vials, PFS, and IV bags. Ensure production schedules are met while maintaining strict adherence to cGMP, FDA, EMA, and other regulatory requirements.
• Partner with Quality Assurance and Regulatory teams to ensure compliance with all applicable regulations. Drive adherence to aseptic standards and lead quality initiatives to minimize risk and improve batch consistency.
• Champion continuous improvement methodologies to enhance efficiency, reduce waste, and optimize production output.
• Build, mentor, and develop a high-performing team. Oversee training in aseptic and cleanroom procedures to maintain high standards and reduce deviations.
• Oversee the validation of new equipment, processes, and sterile filling lines, ensuring proper qualification and readiness for production.
• Manage the manufacturing budget, track expenditures, and identify cost-saving opportunities without compromising product quality or safety.
• Collaborate with R&D, Engineering, and Supply Chain teams to support new product introductions, resolve production issues, and optimize workflow.

Qualifications
:

Education/

Experience:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related field. An advanced degree is a plus.
• Minimum of 15 years of experience in sterile manufacturing, with a focus on vials, pre-filled syringes, or IV bags. Proven experience in a leadership role within a regulated environment is required.

Knowledge, Skills, and Abilities:

• In-depth knowledge of cGMP, FDA, EMA, and other relevant regulations governing sterile manufacturing.
• Strong understanding of aseptic techniques, environmental monitoring, and cleanroom protocols.
• Demonstrated ability to lead and develop a diverse team, fostering a collaborative,…