MS&T Scientist: Sterile Drug Process & Validation

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Pay range $70k-$90k per year

Yearly bonus eligibility

Medical, dental and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals, Inc. in Sacramento, CA is hiring a Scientist – MS&T to support development, scale-up, tech transfer, validation, and commercial manufacturing of sterile products.

You will collaborate with R&D, Manufacturing, Quality, Regulatory, and Supply Chain to ensure compliant, efficient product commercialization. The role emphasizes hands-on technical support, process development, transfer activities, and continued process verification, with a focus on quality, compliance, and

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related field.
• Master's degree or Ph.D. in related field preferred.
• Minimum 3 years of relevant pharmaceutical industry experience with a bachelor's degree, or 1 year with a master's degree; Ph.D. candidates may be considered.
• Experience in Manufacturing Science & Technology (MS&T), process development, manufacturing support, or technical operations.
• Experience with sterile injectable products and cGMP environments.
• Experience supporting technology transfer, process validation, or commercial manufacturing activities.
• Lean Six Sigma or continuous improvement experience.

Responsibilities

• Provide on-site technical support during manufacturing campaigns.
• Collaborate with Operations to identify process improvements that enhance productivity and quality.
• Analyze manufacturing data to identify improvement opportunities and support CPV/PPQ activities.
• Support deviation investigations, change controls, and product impact assessments.

Skills

Lean Six Sigma

cGMP knowledge

Statistical tools

Technical writing

Data trending

Root-cause analysis

Education

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

Master's degree or Ph.D. in related field preferred

Job description

Nivagen Pharmaceuticals, Inc. in Sacramento, CA is hiring a Scientist – MS&T to support development, scale-up, tech transfer, validation, and commercial manufacturing of sterile products.

You will collaborate with R&D, Manufacturing, Quality, Regulatory, and Supply Chain to ensure compliant, efficient product commercialization. The role emphasizes hands-on technical support, process development, transfer activities, and continued process verification, with a focus on quality, compliance, and