Senior Scientist – Formulation Dev (Sterile Injectables)

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 115,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental and vision coverage

Paid time off

Comprehensive benefits

Job summary

Nivagen Pharmaceuticals, Inc. in Sacramento seeks a Senior Scientist to lead formulation development for complex injectable and sterile products, guiding projects from early research through commercialization.

The ideal candidate will design robust formulations using QbD, apply DOE, and mentor team members while coordinating with Regulatory, Operations, and Tech Services to ensure timely delivery. This hands-on role requires a PhD, 7+ years in pharma formulation development, and a track record

Qualifications

• PhD or postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field.
• 7+ years hands-on experience in pharmaceutical formulation development, focusing on sterile/injectable products.
• Solid knowledge of formulation science, excipients, and delivery systems for sterile products.
• Experience with DOE, statistics, and data interpretation.

Responsibilities

• Lead design, development, and optimization of complex injectable and sterile dosage forms from feasibility to commercial readiness.
• Develop risk-based formulation strategies using QbD and FDA guidance to create robust products.
• Apply 505(b)(2)/ANDA knowledge and outsourcing considerations where applicable.
• Design, execute, and interpret DOE studies to meet project objectives.
• Collaborate with Technical Services, Operations, and Regulatory Affairs to enable scale-up and tech transfer.
• Deliver complete formulation data and regulatory documentation within project timelines.
• Monitor regulatory guidance and incorporate updates into programs.
• Provide scientific leadership and mentorship to the team.
• Evaluate new formulation technologies to improve performance and efficiency.
• Author and review protocols, reports, and regulatory documents; communicate findings to stakeholders.

Skills

Sterile/injectable formulation

Scientific leadership

DOE (Design of Experiments)

Regulatory/compliance awareness

Education

PhD or postgraduate in Pharmacy/Pharmaceutical Sciences/Chemistry

Job description

Nivagen Pharmaceuticals, Inc. in Sacramento seeks a Senior Scientist to lead formulation development for complex injectable and sterile products, guiding projects from early research through commercialization.

The ideal candidate will design robust formulations using QbD, apply DOE, and mentor team members while coordinating with Regulatory, Operations, and Tech Services to ensure timely delivery. This hands-on role requires a PhD, 7+ years in pharma formulation development, and a track record