Senior Scientist – Sterile & Injectable Formulations

Nivagen Pharmaceuticals; Sacramento (CA); In loco; USD 115.000 - 140.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental and vision coverage

Paid time off plan

Yearly bonus eligibility

Descrizione del lavoro

Nivagen Pharmaceuticals in Sacramento, CA, is seeking a Sr. Scientist - Formulation Development to lead the development and optimization of complex injectable and sterile drug products from early research through commercialization.

The role blends formulation science with DOE, QbD, and cross-functional collaboration to deliver robust, regulatorily compliant products while mentoring team members and supporting scale-up and technology transfer.

Competenze

• PhD or postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related discipline.
• 7+ years of hands-on experience in pharmaceutical formulation development, with focus on sterile and injectable products.
• Strong knowledge of formulation science, excipients, and drug delivery systems for sterile products.
• DOE, data analysis, and interpretation of results; proven ability to advance formulations to commercialization.

Mansioni

• 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 ensure robust products.
• Apply knowledge of 505(b)(2) and ANDA pathways and 503B outsourcing requirements as applicable.
• Design, execute, and interpret DOE studies to meet project objectives.
• Collaborate with Technical Services, Operations, and Regulatory Affairs to enable scale-up and technology transfer.
• Provide complete formulation development data and regulatory-quality documentation within timelines.

Conoscenze

Design of Experiments

Quality by Design

Statistical analysis

Scientific leadership

Formazione

PhD in Pharmacy

Descrizione del lavoro

Nivagen Pharmaceuticals in Sacramento, CA, is seeking a Sr. Scientist - Formulation Development to lead the development and optimization of complex injectable and sterile drug products from early research through commercialization.

The role blends formulation science with DOE, QbD, and cross-functional collaboration to deliver robust, regulatorily compliant products while mentoring team members and supporting scale-up and technology transfer.