Sep 20, 2022

Job Description

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.

The Associate Director position- (Downstream, Drug Substance, Technical Development), is responsible for the execution and management of process development activities in the area of Cell and Gene Therapy at Novartis. Gene Therapies are a fast growing and exciting area of next generation medicines where our knowledge and impact are advancing rapidly. Our team has a large pipeline of innovative viral vector therapies and needs top talent to join our effort to develop molecules for clinical use to improve outcomes for many of our patients.

Your Key Responsibilities:

• Leads a diverse team of downstream processing scientists in the technical R&D laboratory to deliver processes in support of new pipeline gene therapies.
• Serving as a key scientific and technical representative for downstream processing at internal sites, as well as with external partners.
• Supports and develops the next generation manufacturing processes, planning to avoid delays, and leading activities to deliver a robust and effective product and manufacturing process.
• Ensures all documentation and reports are accurate, complete, and suitable for using in support of development, characterization, and regulatory approval of products.
• Partners with Clinical and Commercial to assure our process design supports safe and effective delivery to the patients.
• Partners with Regulatory and program leads to support submissions and approval of product applications.
• Identifies, recommends and implements potential process improvements in conjunction with MSAT. Participating in start-up efforts of new equipment, software or processes in manufacturing.
• Reviewing/providing feedback and technical/scientific support on project deliverables, (e.g. remediation initiatives, plan reports).
• Builds and maintains a high performing staff of engineers and scientists to support ongoing process and pipeline development as well as process transfers to internal and external manufacturing sites.

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.

Minimum Requirements

What you’ll bring to the Role:

• Bachelors' degree in biochemistry, chemical engineering, bioengineering, or related technical field with 11 years experience in biopharmaceuticals ; Master’s degree with 9 years or PhD with 7 years.
• Excellent oral and written communication skills; attention to detail.
• 11 years direct experience in cell culture, recovery, purification, analytics, and/or aseptic fill/finish processes, process development, and tech transfer.
• Familiar with global regulations, regulatory filings and devices, drugs, validation/qualification requirements.
• Strong organizational skills and ability to multitask across projects and activities.
• Proven ability to effectively lead and participate on teams.
• 7 years leadership experience.
• Up to 20% travel required at times.

Desirable requirements:

• Experience with AAV and lentiviral vector process development.
• Proven ability to lead scientific project teams and influence others with and without direct line authority.

Why Novartis?
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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 protected] 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.
Global Drug Development
Durham, NC
Research & Development
Full Time
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Associate Director - Technical Development Downstream

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