Senior Scientist – Manufacturing Science and Technology; MS&T

Overview

Senior Scientist – Manufacturing Science and Technology (MS&T) role at Nivagen Pharmaceuticals, Inc.

We are seeking a highly skilled and experienced professional to join our Manufacturing Science and Technology (MS&T) team. The successful candidate will play a critical role in the development, scale-up, and continuous improvement of manufacturing processes, ensuring the successful production of high-quality products. This role requires a strong background in process development, optimization, and troubleshooting, combined with expertise in cross-functional collaboration to deliver technical solutions in a fast-paced, dynamic environment.

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 have remained committed to core values of excellence, integrity, and respect for people. Our team collaborates 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 dedication to excellence, we strive to redefine medication accessibility and affordability. We prioritize employees’ well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. Our mission is 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

• Lead process development and optimization efforts for new and existing products, ensuring that they meet both quality and regulatory standards.
• Provide technical expertise in the scale-up of manufacturing processes, from laboratory to commercial production, ensuring process robustness and efficiency.
• Represent product development or CMC development of complex sterile injectable products.
• Collaborate with cross-functional teams including R&D, Quality, Operations, and Regulatory Affairs to resolve technical challenges and drive process improvements.
• Develop and implement process monitoring and control strategies to ensure consistency, reproducibility, and efficiency in manufacturing processes.
• Identify opportunities for process improvements, cost reductions, and risk mitigation in manufacturing operations.
• Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues.
• Prepare manufacturing batch records, technical reports, development reports, and CMC documents to support regulatory submissions (e.g., IND, NDA & ANDA's).
• Define scope, timeline, and resource needs of functional activities and keep the team on schedule.
• Identify and manage external vendors and partners when needed.
• 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.
• Ensure compliance with Good Manufacturing Practices (GMP), health and safety regulations, and other relevant industry standards.
• Extended work hours may be occasionally required based on project needs.
• Additional duties and assignments as needed.

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.)
• Hands-on experience in lab and commercial scale development of complex injectable products.
• Ability to work independently, prioritize tasks, and collaborate effectively with cross-functional teams.
• Proven track record of successful formulation development and commercialization.

Knowledge, Skills, and Abilities:

• Proven track record of successful development and commercialization of sterile dosage forms.
• Strong leadership, project management, and organizational skills.
• In-…