Associate Director, Head of Pre-Clinical Manufacturing

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Job description

Imagine… 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Associate Director, leads both the upstream and downstream teams and plays a lead role in the planning of AAV/LVV production activities for both research grade and GLP grade materials.

Responsibilities

• Plan and execute production for virus vector processes where the production is performed with either adherent or suspension cell culture processes.
• Oversee production schedules, materials, equipment and manpower requirements.
• Author and review relevant process documentation including SOPs/WIs, Protocols, Batch Records, and Technical Reports.
• Effectively and efficiently analyze and interpret data to further progress development strategies.
• Conceive, develop, and implement changes that improve cost, labor, or quality of the manufacturing process for products in development or commercial stages.
• Lead discussions regarding troubleshooting of production processes and/or investigations.
• Play a key role on the receiving end of Technology Transfer from Process Development teams, including establishing guidelines, template, and timeline for TT.
• Supply product of appropriate quality for pre-clinical studies, analytical development, and any other non-clinical needs.
• Author technical reports and documents in support of process development and regulatory filings.
• Develop and motivate a team, providing effective management of resources to deliver on commitments, while maintaining a culture of teamwork, mentorship, and scientific rigor.
• Maintain constant awareness of novel cell culture technologies for AAV production and characterization. Utilize literature and external resources to support internal studies.
• Lead initiatives for evaluation of new technologies and continuous improvement projects.
• Other related duties as assigned.

Qualifications

• B.S. degree in biochemistry, molecular biology, chemical engineering, bioengineering, or related technical field; Master's degree or PhD preferred.
• 8 years of experience in biologics or gene therapy industry experience in technical development.
• Strong technical qualifications including knowledge and application of process development fundamentals
• Extensive experience in process development and scale-up of adherent and suspension cell culture, and single use bioreactor technologies.
• Demonstrated application and knowledge of GxP, GLP and GMP principles and standards.
• Broad and extensive knowledge of DNA transfection, virus production & infection, and critical quality attributes for AAV production.
• Familiar with FDA and EMA guidance documents relevant to gene therapy.
• Demonstrated track record with process development supporting early and late stage development of gene therapy products using a variety of cell culture and bioreactor technologies.
• Proficiency in development and execution of strategic decisions, balancing multiple priorities in a fast-paced environment while promoting a culture of continuous improvement and innovation.
• Strong people management skills and ability to communicate effectively across functions at all levels of the organization. Develops people and manages performance in a manner that is consistent with the Novartis values.
• Deep applied knowledge of upstream process and downstream development operations.
• Approximately 20% travel.

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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Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to call +1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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