Senior Scientist - Formulation Development (R&D)

About the role

Job Type: Full Time
Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA

Responsibilities

• Lead the design, development, and optimization of complex injectable and sterile dosage forms.
• Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA).
• Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues.
• Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives.
• Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs.
• Define scope, timeline, and resource needs of functional activities and keep team on schedule.
• Participate in evaluation of new product opportunities.
• Ensure timely and high-quality documentation for regulatory submissions.
• Stay updated with all FDA and regulatory requirements/guidelines.
• Provide mentorship and leadership to team members.
• Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance.
• Author and review technical reports, protocols, and regulatory documents.

Qualifications

• Education/Experience: Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. 3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development.
• Knowledge, Skills, and Abilities: Proven track record of successful formulation development for various sterile dosage forms, strong leadership, project management, and organizational skills, expertise in complex injectable and sterile dosage form development, demonstrated ability to conduct independent research and problem-solving.

Requirements

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

Benefits

Pay range $70,000-$90,000 per Year
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
401k savings plan