Scientist - Upstream Cell Culture

Novartis; Durham (NC); On-site; USD 94,000 - 174,000; Full time

Job summary

Novartis in Durham, NC seeks an Expert, Science & Technology – Upstream/Cell Culture to lead cell culture and GMP manufacturing support for gene therapy programs. You will work with R&D, analytical development, and pilot-scale operations to deliver scalable processes for AAV/LVV products.

The role emphasizes DOE/QbD studies, process optimization, tech transfer, and regulatory documentation; requires 4–6 years (or advanced degrees) in related fields and strong collaboration skills.

Qualifications

• Bachelor's degree with 4–6 years of relevant experience, or Master's with 2–4, or PhD with 0–2.
• Experience with virus or biologics production from mammalian systems.
• Hands-on with cell lines, bioreactors, and scale-down models.
• Knowledge of biopharmaceutical purification processes.
• Proficiency in DOE, DoE-based experimentation and data analysis.
• Strong communication and teamwork skills; able to work cross-functionally.
• Experience with AAV & LVV processes is preferred.

Responsibilities

• Lead cross-functional experiments and documentation from early development to GMP manufacturing.
• Design and execute time-sensitive studies; capture data and knowledge.
• Stay current with literature and regulatory expectations to inform strategies.
• Apply DOE and QbD to develop and optimize cell culture and vector production.
• Support technology transfer and continuous improvement initiatives.
• Prepare regulatory documents and technical reports; author SOPs.

Skills

Virus production

Cell culture

Bioreactors

DoE

Data analysis

Cross-functional teamwork

Communication

AAV & LVV experience

Regulatory awareness

Education

Bachelor's in biochemistry/biotech

Master's in related field

PhD (preferred)

Job description

Summary

Location: Durham, NC #onsite

Novartis will not sponsor visas for this position.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

This role is required to be in our Durham, NC office 5x/week.

Role Purpose

The Expert, Science & Technology – Upstream/Cell Culture, is responsible for cell & gene therapy (AAV and LVV) upstream process development, optimization and scaling up/down, process characterization, technology transfer and GMP manufacturing support.

About The Role

Major accountabilities

• Leads and support activity with cross-functional organizations to plan, execute, and document experiments and early manufacturing that define the process, and method of delivery to the clinical and commercial sites.
• Design and execution of time-sensitive experiments, studies, and capturing related data and knowledge, to advance the development products from Research to Development to GMP manufacturing.
• Maintains constant awareness of novel biochemical and biophysical technologies for gene therapy production and characterization. Keeps up to date with the scientific literature and developments in the field. Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments. Justifies development strategies and experiment designs.
• Designs and applies DOE and QbD studies to develop, refine, optimize and characterize cell culture and vector production processes. Executes experiments and troubleshoot process and equipment. Conducts laboratory studies to enhance gene therapy manufacturing technologies, capabilities and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
• Supports initiatives for new technology development and continuous improvement projects.
• Provides support for process, analytical, and characterization knowledge related to the production of gene therapy products, and the raw materials needed to make them.
• Tracks records of collaborative relations with groups such as research and development, analytical development, and pilot scale operations.
• Ensures all documentation and reports are accurate, complete, and suitable for using in support of production, characterization, and regulatory filings.
• Writes detailed experimental protocols, develop Bill of Materials (BOM), executes and documents experimental studies according to Standard Operating Procedures (SOPs) or established practices, review and report data.
• Creates and revise SOPs for equipment and process operations.
• Lead the authoring of technical reports and CMC sections for regulatory filings.

Minimum Requirements

• Bachelor's biochemistry, chemical engineering, bioengineering, or related technical field with 4-6 years relevant experience or Master's with 2-4 or PhD with 0-2.
• Extensive experience with production of virus or biologics from mammalian expression systems.
• Hands on experience with different cell lines, bioreactors, and scale-down model is required.
• Organized and systematic approach to viral or biologic production.
• Ability to multi-task and meet tight timelines is essential.
• Knowledge with a variety of biopharmaceutical purification processes.
• Proficient in statistical analysis principles and approaches. Working knowledge and experience with Design of Experiment (DoE).
• Ability to analyze data to make date-driven decisions and further progress development strategies. Innovative with a continuous improvement mindset. Excellent team player with good communication skills. Knowledge of viral cell/gene therapy and previous experience with AAV & LVV processes development is preferred.
• Excellent team player with good communication skills.

Languages

• English.

The salary for this position is expected to range between $93,800 and $174,200 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.