Scientist - Upstream Cell Culture

Novartis • Durham, NC

5d • 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 leads and supports activities 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. It involves the 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. The role requires maintaining constant awareness of novel biochemical and biophysical technologies for gene therapy production and characterization, keeping up to date with the scientific literature and developments in the field, and applying understanding of regulatory expectations to process development strategies. It also includes contributing to process risk assessments and justifying development strategies and experiment designs.

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.
• Languages : 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: Senior