Senior Scientist, Early Pipeline Development (Process Development)

Overview

INNOVATION, QUALITY, COLLABORATION, PERFORMANCE, COURAGE AND INTEGRITY

Over 900+ clinical trials validate that gene therapies are transforming the practice of medicine. As a Senior Scientist for AAV early pipeline process development, you will have an opportunity to join the NIBR Biologics Center (NBC) and be at the cutting edge, leading the development of innovative medicines that can improve lives of patients.

NBC builds the biologics pipeline in collaboration with NIBR Disease Areas and Platforms via a breadth of technologies for discovery of antibody, protein and gene therapy-based therapeutics. The Biotherapeutic Engineering and Gene Therapy (BEGT) group within NBC drives a diverse portfolio of modalities including therapeutic proteins, multi-specific antibodies, CAR-T, RNA therapeutics and rAAV. Through cell and viral engineering as well as innovative and rational protein design, the BEGT group is a global team that works collaboratively with disease area groups to broaden the use of biologics into therapeutic applications where conventional antibodies have limitations.

We are seeking a Process Development Senior Scientist to join the San Diego, CA based BEGT team, supporting early-stage recombinant adenovirus-associated virus (rAAV) gene therapy pipeline portfolio and building improved process technologies for rAAV expression. The candidate will be responsible for leading a 3-5 person team dedicated to early-stage process development with the focus on developability of novel viral platforms and engineered cell lines. The candidate should have extensive experience in rAAV from mammalian expression systems.

Responsibilities

• Leads and manages a team including upstream and downstream.
• Executes adherent and suspension small-scale bioreactor-based cell culture processes for manufacturing of AAV gene therapy vectors across multiple preclinical programs and disease areas.
• Executes downstream process studies, including ultracentrifugation, column chromatography, cell lysis, clarification, AKTA and TFF unit operations, and depth filtration.
• Manages project workflow to ensure on time delivery.
• Contributes to experimental design and execution.
• Provides technical support, training, and SME knowledge to assist with the development of junior staff.
• Coordinates activities with colleagues across downstream process development, analytical development.
• Develops and implements innovative upstream process technologies to improve rAAV process.
• Collaborates with the cell line engineering team to support new and alternative process technologies.
• Develops strategies in collaboration with Disease Areas and partner with various functional teams within NBC to drive early drug discovery from target selection and validation through lead compound selection and developability assessment.
• Develops strategies in collaboration with Technical Research and Development team to advance pipeline programs into clinical phases.
• Prepares written reports conforming to defined documentation practices including electronic lab notebook.
• Other relates duties as assigned.

Qualifications

• Bachelor's Bioprocessing, Biochemical Engineering, or Gene Therapy with 8 years' experience of relevant process development experience in biotechnology/ pharmaceutical environment or Master's with 6 years' experience or PHD with 4 years' experience
• Experience with viral gene therapy is a plus.
• Experience designing and operating adherent culture bioreactor, microbioreactor and single-use small scale stirred-tank bioreactor experiments for mammalian cell culture.
• Experience designing perfusion processes and/or development of medium and feed solutions.
• Knowledge of downstream process. Hands on experience with AKTA purification systems is preferred.
• Knowledge of DoE and JMP.
• Individual team player who demonstrates technical proficiency and creativity, collaboration with others and independent thought. Ability to work in a matrix environment.
• Effective communication including presentations to convey scientific concepts to research scientists and cross-functional collaborators. Ability to work in a matrix environment.
• Strong organization, problem-solving, and project management skills with attention to details.
• Extensive experience in rAAV from mammalian expression systems.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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