Senior Scientist – Manufacturing Science and Technology (MS&T)

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: Senior Scientist – MS&T

We are seeking a highly skilled and experienced Senior Scientist 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.

Responsibilities:

• 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 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.

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. (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-depth understanding of regulatory requirements (FDA, EMA) and GMP
• 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:

• 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

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.