Senior Scientist - Formulation Development (R&D)

About the role

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 Title of the Position: Senior Scientist - Formulation Development We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry.

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.
• Additional duties and assignments as needed.

Requirements

• 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. (Strong candidates with combinations of education and experience will be considered.)
• Strong understanding of formulation principles, excipients, and drug delivery systems.
• Hands-on experience with various formulation techniques and equipment.
• Proven track record of successful formulation development and commercialization.
• Experience with statistical design of experiments (DOE) and data analysis.
• 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.
• Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius).

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