Scientist - MS&T (Manufacturing Science and Technology)

nivagenpharmaceuticals; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Nivagen Pharmaceuticals Inc. is 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 collaborates with senior MS&T staff and cross-functional teams to ensure robust, compliant, and efficient product commercialization, providing hands-on scientific support and process optimization throughout the product lifecycle.

Qualifications

• 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.

Responsibilities

• 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 elevate complex challenges to senior technical staff.
• Participate in root-cause investigations and support implementation of approved corrective and preventive actions (CAPA).
• 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.
• 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.
• 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 QA and RA to ensure compliance and inspection readiness.
• 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.

Education

Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline

Master's degree or Ph.D. in a related scientific discipline

Job description

About the Company:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counterproducts 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 supplychain, 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 innovationand 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, affordablemedications 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 elevate 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 QA and RA 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 expe