Sr. Scientist - Formulation Development

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

Benefits offered by this job

Medical coverage

Paid time off

Annual bonus

Job summary

Nivagen Pharmaceuticals Inc. in Sacramento is seeking a Senior Scientist to lead formulation development for complex injectable and sterile products.

This hands-on role combines formulation science, DOE design, and cross‑functional collaboration to move programs from early research through commercialization. You will mentor team members, ensure regulatory alignment, design robust strategies using QbD, and deliver clear documentation for submissions, while staying aligned with FDA guidance and

Qualifications

• 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.

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 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.

Skills

Formulation leadership

Experimental design

Cross-functional collaboration

Regulatory awareness

Education

Ph.D. or equivalent

Pharmaceutical Sciences background

Job description

About the Company:

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we’ve remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees’ well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people’s lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Type:

Full Time

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

About the Job:

Title of the Position: Sr. Scientist - Formulation Development

We 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

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.