Job Type:Full Time
Job Location:Nivagen Pharmaceuticals Inc., Sacramento, CA
About the Job: Title of the Position:
Sr. Scientist - Formulation DevelopmentWe are seeking an experienced Senior Scientist to lead the development and optimization of complex injectable and sterile drug products, from early-stage research through commercialization. This hands-on scientific role combines formulation expertise, experimental design, and technical problem-solving with cross-functional collaboration. The successful candidate will develop scientifically sound formulation strategies, deliver high-quality technical documentation, and mentor team members to advance development programs
Responsibilities:- Lead the design, development, and optimization of complex injectable and sterile dosage forms, from formulation feasibility through commercial readiness.
- Develop risk-based formulation strategies using Quality by Design (QbD) principles and applicable FDA guidance to establish robust, reproducible drug products.
- Apply knowledge of 505(b)(2) and Abbreviated New Drug Application (ANDA) development pathways, as well as Section 503B outsourcing requirements, as applicable to each program.
- Design, execute, and interpret formulation studies using statistical design of experiments (DOE), including factorial designs, to resolve technical challenges and achieve project objectives.
- Partner with Technical Services, Operations, and Regulatory Affairs to align development activities, support scale-up and technology transfer, and resolve formulation-related manufacturing challenges.
- Deliver accurate, complete formulation development data and supporting documentation within agreed project timelines for regulatory submissions.
- Monitor relevant FDA requirements and regulatory guidance, assess their impact on development programs, and incorporate applicable updates into project activities.
- Provide scientific leadership and hands-on mentorship to team members in experimental design, data interpretation, and formulation troubleshooting.
- Evaluate emerging formulation technologies and scientific advances for their potential to improve product performance and development efficiency.
- Author and review study protocols, technical reports, and formulation-related regulatory documents; communicate findings and recommendations to cross-functional stakeholders.
Education/Experience:- Ph. D. or postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related discipline.
- At least 7 years of hands-on experience in pharmaceutical formulation development, with a focus on sterile and injectable drug products.
- Strong knowledge of formulation science, excipient selection, and drug delivery systems relevant to sterile and injectable products.
- Hands-on proficiency with formulation development techniques and laboratory equipment used for sterile and injectable dosage forms.
- Demonstrated success advancing pharmaceutical formulations through development and commercialization.
- Practical experience in statistical design of experiments (DOE), data analysis, and interpretation of experimental results.
Knowledge, Skills, and Abilities:- Ability to translate scientific findings into actionable formulation strategies and communicate technical conclusions clearly.
- Strong scientific leadership, project management, and organizational skills, with the ability to prioritize activities and meet project milestones.
- Expertise in complex injectable and sterile dosage form development, including the ability to identify formulation risks and evaluate scientifically justified solutions.
- Ability to conduct independent research, troubleshoot complex technical problems, and collaborate effectively across functions.
Requirements:- Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius).
Benefits:- Pay range $115,000- $140,000 per Year (Based on Experience)
- Yearly bonus eligibility
- Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
- Medical, dental and vision coverage
- Paid time off plan
