12,000. The number of associates worldwide working together to reimagine medicine!
The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.
This position may be based in San Diego, California, Durham, North Carolina, or East Hanover, New Jersey.
What you'll be doing:
• You will lead and coordinate the drug substance CMC sub-team and represent the drug substance process discipline in the global CMC project team of assigned programs
• You are accountable for managing all drug substance development activities including process development, tech transfer, GMP manufacturing technical support, etc.
• You will need to communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc.
• You will proactively identify scientific, technological and GMP issues and risk mitigation, propose creative solutions and communicate key issues to the appropriate management level
• You are responsible for high quality drug substance process registration documents for HA submissions and interacting with authorities, act as technical expert in audits, inspections etc.
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
What you'll bring:
• Bachelor's, biological sciences, pharmaceutical sciences or related technical field with 8 years relevant experience or Master's with 6 years of relevant experience, or PHD with 4 years of relevant experience.
• Previous Experience in Upstream / Downstream Process Development; expertise in Upstream Process with complementary knowledge of Downstream Process (or vice versa)
• Previous experience in large molecule drug substance process development; prior experience in lentivirus gene therapy process development preferred
• Strong working knowledge of regulatory CMC expectations with significant experience with IND/BLA submissions
• Strong understanding of the drug development process, and working knowledge of the strategic and operational aspects of the gene therapy space preferred
• Proven leader that can effectively operate in a cross-functional, matrix environment and successfully manage multiple programs / priorities simultaneously
• Ability to provide strategic guidance to DS CMC development activities for gene therapy programs and also provide tactical support (i.e. technical expertise, project management, etc) to drive programs forward
• A collaborative attitude, excellent communication skills and problem solving mentality are essential for success
• Up to 10% travel
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to email@example.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.