Jun 10, 2022

Job Description

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

What you'll be doing:
• Leads and supports projects within the research and development drug product laboratory to enhance manufacturing cell and gene therapy technologies, capabilities, and processes.
• Design and independently execute cell and gene therapy drug product process development studies supporting pre-clinical, clinical, and commercial operations.
• Safely and compliantly execute daily lab operations for drug product process development studies, depending on job specific assignment. Collaborates with cross-functional groups to coordinate studies.
• Support tech transfer of new products, technologies, and processes to ensure smooth transition from process development into GMP manufacturing.
• Capable of evaluating and summarizing data using analytical methodologies, interpreting results, drawing conclusions, and recommending options for future experiments to achieve project goals.
• Authors technical documents and presents results of development studies both internally and externally.
• Advance drug product process innovations through cross-functional collaboration teams across Novartis sites and organizations.
• Assists the evaluation and introduction of new technologies.

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:
• Minimum 3+ years of experience in a biopharmaceutical-based manufacturing or process development setting, including experience in sterile filtration, aseptic fill-finish, and drug delivery. Working knowledge of FDA regulations and GMP systems is preferred.
• Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field; Master’s degree preferred.
• Good knowledge or experience of laboratory skills and technical tools.
• Experience with 3rd parties (equipment vendors, and contract manufacturing insourcing/outsourcing) is preferred.
• Ability to effectively and efficiently analyze and interpret data to further progress development strategies.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Ability to motivate peers and staff, foster a culture of continuous improvement and operational excellence.
• 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).
• Knowledge of viral gene therapy and previous experience with adeno-associated virus (AAV) and/or lentiviral vectors (LVV) process development is preferred.

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.

Global Drug Development
Durham, NC
Research & Development
Full Time
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Associate Expert – Drug Product (Process Development Scientist)

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