Sr. Scientist - Formulation Development

Nivagen Pharmaceuticals•Sacramento, CA

6d•$115,000 - $140,000•Onsite

About The Position

Nivagen is 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, technical problem-solving, and cross-functional collaboration. The successful candidate will develop scientifically sound formulation strategies, produce high-quality technical documentation, and mentor team members to advance development programs. The role is based at Nivagen Pharmaceuticals Inc. in Sacramento, California. The candidate must live in or be willing to move to the Sacramento Metropolitan Region, approximately 40 miles in radius. Nivagen develops and provides cost-effective generic prescription drugs and over-the-counter products for the North American market, with a focus on excellence, integrity, respect, and improving medication accessibility and affordability.

Requirements

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.
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.
Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius).

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.