Sr. Scientist – Manufacturing Science and Technology (MS&T)
About The Position
Nivagen is seeking a highly motivated and experienced Senior Scientist in Manufacturing Science & Technology (MS&T) to support the development, scale-up, technology transfer, validation, and commercial manufacturing of sterile pharmaceutical products. The role serves as a technical expert connecting Research & Development, Manufacturing, Quality, Regulatory Affairs, and Supply Chain to enable robust, compliant, and efficient product commercialization. The successful candidate will apply scientific and engineering expertise to improve processes, troubleshoot manufacturing challenges, support continuous improvement, and execute technology transfer and lifecycle management activities. The position provides technical leadership for manufacturing processes supporting commercial and late-stage development products. It leads technology transfer from R&D to manufacturing and between sites, and supports process validation, continued process verification, and process performance qualification. The scientist provides real-time campaign support, analyzes manufacturing data, leads investigations, and collaborates with Operations and other functions to improve productivity, yield, and product quality. The role also helps ensure compliance with cGMP, FDA, ICH, and global regulatory requirements; supports submissions, inspections, and agency responses; and partners with Quality Assurance and Regulatory Affairs on inspection readiness. It provides technical recommendations to leadership and project teams and mentors junior scientists and engineers. The position is based at Nivagen Pharmaceuticals Inc. in Sacramento, California; candidates must live in or be willing to move to the Sacramento Metropolitan Region, approximately 40 miles in radius.
Requirements
- Minimum 7 years of pharmaceutical industry experience.
- Significant experience in 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.
- Strong knowledge of pharmaceutical manufacturing processes and process characterization.
- 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.
- Ability to influence cross-functional teams without direct authority.
- Strong project management and organizational skills.
- Exceptional communication and stakeholder management abilities.
- Ability to mentor and develop technical talent.
- Results-oriented mindset focused on quality, compliance, and continuous improvement.
- Must live in or be willing to move to the Sacramento Metropolitan Region, approximately 40 miles in radius.
Nice To Haves
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline.
- Experience with sterile injectable products, including IV bags, vials, prefilled syringes (PFS), and cartridges.
- Experience supporting regulatory inspections and agency interactions.
- Lean Six Sigma or continuous improvement experience.
- Experience with commercial manufacturing lifecycle management.
- Master's degree with significant industry experience may be considered.
Responsibilities
- Serve as technical lead for manufacturing processes supporting commercial and late-stage development products.
- Provide scientific expertise for process development, scale-up, validation, and commercial manufacturing.
- Evaluate and resolve complex manufacturing, formulation, and process-related challenges using data-driven approaches.
- Lead root-cause investigations and implement corrective and preventive actions (CAPA).
- 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).
- Author and review BMRs, BPRs, technical protocols, reports, technical assessments, and risk analyses.
- Ensure manufacturing processes remain robust, scalable, and compliant throughout the product lifecycle.
- 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.
- Support deviation investigations, change controls, and product impact assessments.
- 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.
- Partner with Quality Assurance and Regulatory Affairs to ensure compliance and inspection readiness.
- Collaborate with R&D, Analytical Development, Operations, Quality, Regulatory Affairs, Engineering, Validation, and Supply Chain teams.
- Provide technical recommendations to senior leadership and project teams.
- Mentor junior scientists and engineers and foster scientific excellence and continuous learning.
Benefits
- Yearly bonus eligibility.
- Medical, dental, and vision coverage.
- Paid time off plan.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
