Scientist - Upstream Cell Culture

Novartis • Durham, CA

1d • $93,800 - $174,200 • Onsite

About The Position

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

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.
• English.

Nice To Haves

• Knowledge of viral cell/gene therapy and previous experience with AAV & LVV processes development is preferred.
• Excellent team player with good communication skills.

Responsibilities

• 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.

Benefits

• health
• life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level