Expert, Science & Technology (Upstream)

Your Key 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.

Requirements:

• Bachelor's biochemistry, chemical engineering, bioengineering, or related technical field with 4 years relevant experience or Master's with 2 or PhD.
• 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.
• 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 gene therapy and previous experience with AAV process development is preferred.
• Excellent team player with good communication skills.

Desired Requirements:

• Knowledge with a variety of biopharmaceutical purification processes.
• Knowledge of viral gene therapy and previous experience with AAV process development is preferred.

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: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: 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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between$102,400-$153,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period.  Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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