344151BR
Apr 27, 2022
USA

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

What you'll be doing:
•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.
• Acts as team leader of the assigned team
• Influences, leads and manages all project/network/platform activities and applies scientific/technical expertise
• Advances complex drug product process development efforts as a technical lead within a cross-functional team across Novartis sites and organizations.
• Leads projects within the drug product unit to enhance manufacturing gene therapy technologies, capabilities, and processes.
• Independently plans, designs, executes and interprets complex development studies (with multiple experiment sets) related to process development and scale-up, ensuring studies balance time and resources. Drives results and generates innovative solutions; takes independent action to solve scientific problems and drive their resolution.
Provide scientific and technical input for Drug Product/Fill-Finish process-related issues at internal Novartis sites, as well as with external partners.
Identify and implement potential process improvements in conjunction with manufacturing operations.
Provide technical/scientific support in process development and qualification efforts in pre-clinical and clinical manufacturing through laboratory studies designed to illuminate fundamental process and product performance (e.g. NOR & PAR setting, CPP edge of failure, CQA performance).
Support tech transfer and participate in start-up efforts of new products, equipment, software or processes in manufacturing.
Support regulatory applications as subject matter expert for Drug Product/Fill-Finish operations and process development experiments.

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:
• Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field; Master’s degree or PhD preferred.
• Minimum 10 years of experience (with a Bachelor’s degree) in biopharmaceutical based process development including direct experience in sterile filtration, aseptic fill-finish and drug delivery; prior experience in lentivirus gene therapy process and/or formulation development preferred.
• Familiar with global regulations on drug product and validation/qualification requirements.
• Ability to effectively and efficiently analyze and interpret data to further progress development strategies.
• A collaborative attitude, excellent communication skills and problem solving mentality are essential for success.
• Approximately 10% travel may be required.

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.


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.

https://www.novartis.com/careers/careers-research/notice-all-applicants…
Global Drug Development
TECHNICAL R & D GDD
USA
Durham, NC
Research & Development
Full Time
Regular
No
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344151BR

Associate Director, Science & Technology

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