Scientist – Manufacturing Science and Technology - Manufacturing Science and Technology

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 Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

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.

Responsibilities:

Scientific & Technical Support

• Execute assigned technical activities supporting manufacturing processes for commercial and late-stage development products.

• Support process development, scale-up, validation, and commercial manufacturing activities through study execution, data collection, and analysis.

• Evaluate manufacturing, formulation, and process-related issues using data-driven approaches and escalate complex challenges to senior technical staff.

• Participate in root-cause investigations and support implementation of approved corrective and preventive actions (CAPA).

Technology Transfer & Process Validation

• Support technology transfer activities from R&D to manufacturing and between manufacturing sites, completing assigned tasks under technical lead guidance.

• Assist in planning and executing process validation, continued process verification (CPV), and process performance qualification (PPQ) activities.

• Prepare and revise BMR, BPR, technical protocols, reports, technical assessments, and risk analyses for review by senior technical staff and relevant functions.

• Monitor assigned process parameters and support assessments of process robustness, scalability, and compliance throughout the product lifecycle.

Manufacturing Support

• Provide on-site technical support during manufacturing campaigns, with guidance from senior MS&T staff as needed.

• Collaborate with Operations to identify process improvements that enhance productivity, yield, and product quality.
• Analyze manufacturing data and trends to identify improvement opportunities and support approved continuous process improvement initiatives.
• Support deviation investigations, change controls, and product impact assessments.

Regulatory & Quality Compliance

• Perform assigned activities in accordance with approved procedures, cGMP, and applicable FDA, ICH, and global regulatory requirements.

• Compile technical data and documentation to 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, Operations, Quality, Regulatory Affairs, Engineering, Validation, and Supply Chain teams to complete assigned project activities.

• Present study results, technical observations, and recommendations to senior scientists and project teams.

• Share technical knowledge with colleagues and participate in training and continuous learning activities.

Qualifications:

Education/Experience:

• 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.

Technical Knowledge and Skills:

• 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.

Requirements:

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

Benefits:

• Pay range $70,000-$90,000 per Year (Based on Experience)
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• 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.