Senior Scientist: Sterile Injectable Formulation & Development

nivagenpharmaceuticals; Sacramento (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Nivagen Pharmaceuticals Inc. in Sacramento is seeking a Sr. Scientist to lead formulation development for complex injectable and sterile products, from early research through commercialization.

This hands-on role blends formulation science with experimental design and cross-functional collaboration. The ideal candidate will have a PhD and 7+ years in pharmaceutical formulation development, with expertise in DOE, QbD, and regulatory documentation to support FDA submissions.

Qualifications

• 7+ years in pharmaceutical formulation development, with a focus on sterile and injectable products.
• Experience with QbD, FDA guidance, and regulatory documentation.
• Strong analytical and problem-solving skills.

Responsibilities

• Lead design and optimization of complex injectable/sterile dosage forms.
• Develop risk-based formulation strategies using QbD and FDA guidance.
• Apply DOE to resolve technical challenges and meet objectives.
• Collaborate across Technical Services, Operations, and Regulatory Affairs.
• Deliver complete development data and docs for regulatory submissions.

Skills

Leadership

Project management

Statistical DOE

Formulation strategy

Education

Ph.D. in Pharmacy or Pharmaceutical Sciences or Chemistry

Tools

DOE

Job description

Nivagen Pharmaceuticals Inc. in Sacramento is seeking a Sr. Scientist to lead formulation development for complex injectable and sterile products, from early research through commercialization.

This hands-on role blends formulation science with experimental design and cross-functional collaboration. The ideal candidate will have a PhD and 7+ years in pharmaceutical formulation development, with expertise in DOE, QbD, and regulatory documentation to support FDA submissions.