Nivagen Pharmaceuticals, Inc. · 1 month ago
Manufacturing Head - Sterile Manufacturing (Vials, PFS & IV Bags)
Sacramento, CA 95834
Full-time
Onsite
Director/Executive
15+ years expNivagen Pharmaceuticals is a global company dedicated to improving lives through affordable generic drugs. They are seeking a Manufacturing Head to lead sterile production operations for vials, pre-filled syringes, and IV bags, ensuring compliance with regulatory standards and driving operational excellence.
ManufacturingMarket ResearchPharmaceutical
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
Qualification
Required
Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field
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
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
Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius)
Preferred
An advanced degree is a plus
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
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-07
2025-05-23
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