Apr 27, 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 Analytical Development Operations (ADO) group is responsible for developing analytical technologies and applying them to support viral vector development for cell and gene therapies. ADO supports chemistry, manufacturing and control (CMC) activities from the earliest stages of product candidacy through commercial licensure. Within ADO, the Senior Expert, Science & Technology, Analytical Project Lead (APL) is responsible for identifying critical quality attributes (CQA) of a viral vector candidate and developing analytical strategies and methods for monitoring CQAs throughout product development. The APL works within a cross functional CMC team to design, coordinate, and execute studies that demonstrate Novartis understands and appropriately controls the quality of our product and process. The APL position offers the opportunity to develop and apply rapidly advancing analytical technologies necessary to ensure Novartis consistently delivers safe and efficacious cell and gene therapies.

Your responsibilities include, but are not limited to:

• Produce product CQA assessment, analytical strategy, specifications, and comparability strategies/criteria
• Lead the development, qualification, transfer, and validation of analytical methods among multiple internal and external analytical laboratories
• Lead cross-functional and cross-site product characterization and investigations
• Provide technical expertise and leadership as you collaborate within and across cross-functional teams to support process development and establish control strategy
• Provide strategic recommendations across the network
• Serve as a key scientific and technical representative on cross-functional teams (CMC, Regulatory, Quality, Manufacturing, etc.)
• Write, review, and/or approve experimental protocols/reports and regulatory submissions
• Respond to questions from regulatory authorities regarding analytical topics and specifications

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:

• BS/BA in relevant field with 8 years’, MS with 6 years’, or Ph.D. with 4 years’ experience in biopharmaceutical industry
• A critical thinking mindset, problem-solving skills, and the interpersonal communication, scientific writing, and presentation abilities to provide effective leadership
• Solid organizational skills and ability to prioritize simultaneous projects and activities
• Proven ability to effectively lead and participate on teams, often via tele/video conference
• Passion for continuous learning and capability to work in a highly dynamic, fast-paced, collaborative environment is key to the success of this role.

Desirable Skill Sets:
• Experience with analytical support for biologic product commercialization, especially in cell/gene therapy field
• Proven background in protein/nucleic acid chemistry/biochemistry/analytical chemistry
• Experience preparing regulatory filings and other correspondence/interactions with regulatory agencies
• Project management experience
• Understanding of GMP requirements and regulations (FDA/EMA/ICH etc.)

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
Durham, NC
Research & Development
Full Time
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Sr Expert, Science & Technology (Analytical Project Lead)

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