Senior Scientist - Manufacturing Science and Technology (MS&T)

About the Company:

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.

Job Type:

Full Time

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

About the Job:

Title of the Position: Senior Scientist – MS&T

We are seeking a highly motivated and experienced Sr. Scientist, Manufacturing Science & Technology (MS&T) to support the development, scale-up, technology transfer, validation, and commercial manufacturing of sterile pharmaceutical products. This role serves as a key technical expert bridging Research & Development, Manufacturing, Quality, Regulatory Affairs, and Supply Chain functions to ensure robust, compliant, and efficient product commercialization. The successful candidate will leverage strong scientific and engineering expertise to drive process excellence, troubleshoot manufacturing challenges, support continuous improvement initiatives, and ensure successful execution of technology transfer and lifecycle management activities.

Responsibilities:

Technical Leadership

• Serve as the technical lead for manufacturing processes supporting commercial and late-stage development products.
• Provide scientific expertise for process development, scale-up, validation, and commercial manufacturing activities.
• Evaluate and resolve complex manufacturing, formulation, and process-related challenges using data-driven approaches.
• Lead root-cause investigations and implement effective corrective and preventive actions (CAPA).

Technology Transfer & Process Validation

• Lead technology transfer activities from R&D to manufacturing and between manufacturing sites.
• Design and support process validation, continued process verification (CPV), and process performance qualification (PPQ) activities.
• Author and review BMR, BPR, technical protocols, reports, technical assessments, and risk analyses.
• Ensure manufacturing processes remain robust, scalable, and compliant throughout the product lifecycle.

Manufacturing Support

• Provide real-time technical support during manufacturing campaigns.
• Collaborate with Operations to identify process improvements that enhance productivity, yield, and product quality.
• Analyze manufacturing data and trends to drive continuous process improvement initiatives.
• Support deviation investigations, change controls, and product impact assessments.

Regulatory & Quality Compliance

• Ensure manufacturing processes comply with cGMP, FDA, ICH, and global regulatory requirements.
• Support regulatory submissions, inspections, and agency responses related to manufacturing and process development activities.
• Partner with Quality Assurance and Regulatory Affairs to ensure compliance and inspection readiness.

Cross-Functional Collaboration

• Collaborate with R&D, Analytical Development, Operation, Quality, Regulatory Affairs, Engineering, Validation, and Supply Chain teams.
• Provide technical recommendations to senior leadership and project teams.
• Mentor junior scientists and engineers while fostering a culture of scientific excellence and continuous learning.

Education:

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline preferred.
• Master's degree with significant industry experience may be considered.

Experience:

• Minimum 7 years of pharmaceutical industry experience.
• Significant experience within Manufacturing Science & Technology (MS&T), process development, manufacturing support, or technical operations.
• Experience supporting sterile, injectable, parenteral, or aseptic manufacturing processes.
• Proven experience with technology transfer, process validation, and commercial manufacturing support.
• Experience working in a cGMP-regulated environment.

Technical Knowledge & Skills:

• Strong knowledge of pharmaceutical manufacturing processes and process characterization.
• Experience with sterile and injectable drug products preferred.
• Understanding of Quality by Design (QbD), risk management, and statistical tools.
• Experience with process monitoring and continued process verification.
• Strong investigation, troubleshooting, and root-cause analysis capabilities.
• Knowledge of FDA, EMA, ICH, and global regulatory requirements.
• Excellent technical writing, documentation, and presentation skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Leadership Competencies:

• Demonstrated ability to influence cross-functional teams without direct authority.
• Strong project management and organizational skills.
• Exceptional communication and stakeholder management abilities.
• Ability to effectively mentor and develop technical talent.
• Results-oriented mindset with a focus on quality, compliance, and continuous improvement.

Preferred Qualifications:

• • Experience with sterile injectable products (in IV bag, Vial, PFS and Cartridge).
  • Experience supporting regulatory inspections and agency interactions.
  • Lean Six Sigma or continuous improvement experience.
  • Experience with commercial manufacturing lifecycle management.

Requirements:

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

Benefits:

• $85,000-$115,000 Annual Salary (Based on Experience) 
• Yearly Bonus Eligibility 
• Medical, dental and vision coverage
• Paid time off 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.