342123BR
Mar 24, 2022
USA

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.

**This role has the ability to be located in Durham, NC or San Diego, CA.

The Associate Director, Science & Technology - Virology, leads a function in process design, experimental design & execution, scale model development, investigational testing for operations support as well as platform development project planning, execution, and therapeutic product program development from a Virological perspective. The candidate will also shape and develop strategic direction and drive operational excellence in line with TRD vision and strategy as well as ensure full portfolio support in line with GDD, Sandoz, NTO and NIBR plans. The ideal candidate will bring expertise and perspective to the process development team that leverages a deep knowledge of recombinant/molecular/reverse genetic approaches to virus production.

Your responsibilities will include, but are not limited to:

• Leads and manages all project/network activities and apply scientific/technical expertise to address complex R&D issues and actively support TRD strategies and goals by participating in cross-functional teams.
• Leads scientific programs; coordinates interdisciplinary projects and teams.
• Develops long term strategies and applies and/or develops highly advanced technologies, scientific principles, theories and concepts.
• Often acts independently to uncover and resolve problems associated with the development and implementation of operational programs.
• Process development activities leveraging viral knowledge in drug substance (upstream, intermediate and downstream), drug product (formulation, filling, packaging and labeling) and critical raw materials, as well as media and buffer manufacturing; opportunity to collaborate in the multiple technical development areas.
• Supports scientific decision making by providing advice and recommendations to global project teams. Develop concepts and propose approach, to address identified medical device/science/technology needs.
• Serves as the SME in technical team discussions of how process changes will affect the virus/vector and makes recommendations/conducts experiments to mitigate and investigate how the vector will be affected.
• Supply technical advice and counsel to other professionals and represent the organization in outside discussions and technical forums.
• Directs outputs of team, project or business activity, often across locations.
• Advises on, and as needed directs, the activity of scientific & engineering staff. This position may have up to 1-5 direct reports.
• Leads projects within the technical development unit to enhance AAV/lentivirus production and capture technology capability and performance.
• Independently designs/executes and/or directs development studies relating to vector and cargo while ensuring individual experiments balance time and resources.
• Ensures all documentation and reports are accurate, complete, and suitable for use in support of platform development summary reporting, manufacturing records development as well as quality investigations and regulatory dossiers.
• Troubleshoots scientific and technical challenges, contributes to and/or leads their resolution. Leads and mentor junior colleagues while fostering a team environment committed to the principles of scientific excellence.
• Serve as a biosafety expert for internal safety programs with regard to impact of virus/vector risk to personnel.

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:

• 7+ years of related experience in the field of virology within the pharmaceutical, biotechnology, or advanced therapies industry.
• Advanced degree in in virology, molecular biology, genetics or related technical field is strongly preferred.
• Broad knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment. The proven ability to lead/influence broad technical teams in a matrix environment is required for this role.
• In-depth knowledge of AAV/virus based product/process development including transfection development, scale-up, and significantly improving process performance.
• Understanding of, and experience with, global regulations pertaining to cGMP manufacturing of Drug Substance and/or Drug Product and the translation of those regulations into process development work products.
• May require up to 10% travel when necessary.

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!

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.


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
TECHNICAL R & D GDD
USA
Durham, NC
Research & Development
Full Time
Regular
No
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342123BR

Associate Director, Head of Virology - Durham / San Diego

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