347939BR
Jul 01, 2022
USA

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

Novartis Cell and Gene Therapies is seeking a responsible Project Manager for supporting project management activities within the Process Development group interfacing with Manufacturing, R&D, CMC Regulatory, and third parties. This position is critical in coordinating the completion of process and product source documents to support process development, manufacturing, and FDA/EMA filing requirements and ensure the development teams are prepared for GMP production, process transfers, regulatory authority meetings, IND updates, BLA filing and CTA filing.

What you'll be doing:

• In close collaboration with the PMO, Product Leads and Core Team, develop, implement, and manage technical development plans for new gene therapy programs. This includes budgets, timelines and schedules, resources, critical milestones, risk management etc.
• Includes projects in various stages: preclinical, clinical, tech transfer, and commercial.
• Experience managing direct reports and project managers including coaching and developing junior PM staff
• Management of Process Development deliverable timelines to support regulatory meetings and filings (IND/BLA/CTA).
• Prepare weekly/monthly metrics and progress dashboards reflecting status of development and relevant manufacturing activities.
• Communication of program strategy, progress, and issues to company leadership and other key stakeholders. Highlight and escalate issues along with mitigation options/solutions i.e. maintain risk register
• Facilitate and manage productive team communication and collaboration, both internally and externally (agenda, minutes, follow-up on actions, etc.)

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you'll bring:

• Minimum B.S. degree in science related field; higher level degree & PMP Certification highly preferred.
• 6-8 years experience working with the development of rare/orphan disease products, preferably with Lentiviral Vector Platform within gene therapy
• Direct, hands-on experience in manufacturing, quality, and CMC regulatory experience; direct experience with INDs, BLAs and CTAs preferred.
• Strong understanding of drug substance and/or drug product development process including strategic and operational aspects
• Demonstrated experience in project management with a proven track record of effectively managing multiple projects / priorities simultaneously
• Ability to synthesize detailed information and provide critical insights across manufacturing and supply chain.
• Up to 20% travel.

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

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. 

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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 [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants…
Global Drug Development
TECHNICAL R & D GDD
USA
San Diego, CA
Research & Development
Full Time
Regular
No
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347939BR

Senior Project Manager, PMO Process Development

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