MS&T Scientist: Sterile Pharma Scale-Up & Tech Transfer

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

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.