Upstream Cell Culture Scientist: Gene Therapy Process Dev

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

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.