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

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

Manufacturing Head – Sterile Manufacturing (Vials, PFS & IV Bags) – Join Nivagen Pharmaceuticals, Inc. to lead our sterile production operations.

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 excellence, integrity, and respect for people, advancing manufacturing, distribution, and quality control with a comprehensive approach to healthcare.

Job Location

Nivagen Pharmaceuticals, Inc., Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834

About the Job

Title: 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 ensures 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, 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, high‑performance culture.
• Ability to use data‑driven approaches for problem‑solving, risk assessment, and decision‑making.

Requirements

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

Benefits

• Competitive salary + annual bonus eligibility
• Medical, dental and vision coverage
• Paid time off plan
• 401(k) savings plan

Additional Information

Nivagen offers equal opportunity employment to all individuals regardless of race, color, age, national origin, disability, sexual orientation, gender identity, marital status, or any other factor prohibited by law. We prohibit harassment or retaliation based on any of these factors and encourage a diverse and inclusive workforce.

We are focused on building a diverse and inclusive workforce. If you’re excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Seniority Level

Director

Employment Type

Full‑time

Job Function

Management and Manufacturing

Industry

Pharmaceutical Manufacturing