Scientist – MS&T (Manufacturing Science and Technology)

Nivagen Pharmaceuticals • Sacramento, CA

6d • $70,000 - $90,000 • Onsite

About The Position

Nivagen Pharmaceuticals Inc. is seeking a highly motivated Scientist, Manufacturing Science & Technology (MS&T) to support development, scale-up, technology transfer, validation, and commercial manufacturing of sterile pharmaceutical products. The role provides hands-on scientific and technical support and works with senior MS&T staff and functions across Research & Development, Manufacturing, Quality, Regulatory Affairs, and Supply Chain to support robust, compliant, and efficient product commercialization.

The Scientist executes assigned technical activities, supports manufacturing campaigns and process improvement, contributes to investigations and validation activities, and prepares technical documentation. The position works under guidance from senior technical staff on assigned activities and collaborates with cross-functional project teams. The job is located at Nivagen Pharmaceuticals Inc. in Sacramento, California. Candidates must live in or be willing to move to the Sacramento Metropolitan Region, approximately a 40-mile radius.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline.
• At least 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 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 bags, vials, prefilled syringes (PFS), and cartridges.
• Experience preparing technical documentation for regulatory inspections or agency responses.
• Working knowledge of pharmaceutical manufacturing processes and process characterization principles.
• 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.
• Must live in or be willing to move to the Sacramento Metropolitan Region, approximately a 40-mile radius.

Nice To Haves

• Master’s degree or Ph.D. in a related scientific discipline.
• Experience with sterile and injectable drug products.
• Lean Six Sigma or continuous improvement experience.
• Experience with commercial manufacturing lifecycle management.

Responsibilities

• Execute assigned technical activities supporting manufacturing processes for commercial and late-stage development products.
• Support process development, scale-up, validation, and commercial manufacturing 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).
• Support technology transfer 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 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 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.

Benefits

• Yearly bonus eligibility.
• Medical, dental, and vision coverage.
• Paid time off plan.
• A wide variety of benefits and programs to support health and well-being.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level