Scientist – MS&T (Manufacturing Science and Technology)

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

Title of the Position: Scientist – MS&T (Manufacturing Science and Technology)

We are seeking a highly motivated Scientist, Manufacturing Science & Technology (MS&T) to support the development, scale-up, technology transfer, validation, and commercial manufacturing of sterile pharmaceutical products. This role contributes hands-on scientific and technical support, working with senior MS&T staff and Research & Development, Manufacturing, Quality, Regulatory Affairs, and Supply Chain functions to support robust, compliant, and efficient product commercialization. 

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline required. 
• Master’s degree or Ph.D. in a related scientific discipline preferred.
• Minimum 3 years of relevant pharmaceutical industry experience with a bachelor’s degree, or 1 year with a master’s degree; candidates with a relevant Ph.D. and applicable research experience may be considered. 
• Relevant experience in Manufacturing Science & Technology (MS&T), process development, manufacturing support, or technical operations. 
• Experience or practical exposure to sterile, injectable, parenteral, or aseptic manufacturing processes. 
• Experience supporting technology transfer, process validation, or commercial manufacturing activities. 
• Experience working in a cGMP-regulated environment. 
• Experience with sterile injectable products (in IV bag, Vial, PFS and Cartridge).
• Experience preparing technical documentation for regulatory inspections or agency responses.
• Lean Six Sigma or continuous improvement experience. 
• Experience with commercial manufacturing lifecycle management.

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

• Working knowledge of pharmaceutical manufacturing processes and process characterization principles. 

• Experience with sterile and injectable drug products preferred. 

• Understanding of Quality by Design (QbD), risk management, and statistical tools. 

• Familiarity with process monitoring, data trending, and continued process verification. 

• Ability to apply structured investigation, troubleshooting, and root-cause analysis methods with appropriate guidance. 

• Working knowledge of cGMP and familiarity with applicable FDA, EMA, ICH, and global regulatory requirements. 

• Effective technical writing, documentation, and presentation skills. 

• Ability to organize and complete assigned tasks across multiple projects and communicate competing priorities in a fast-paced environment.

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.