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Associate Director, Technology Transfer Project Lead

Novartis

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East Hanover, NJ
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Job Description

As posted by the hiring company

Job Overview:

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.

As the Technology Transfer Project Lead you will be in charge of the technology transfers for the Cell and Gene Therapy programs. You will lead technology transfers from beginning to end between the transferring and receiving site for process and analytical technologies. You will also be trusted with guiding cross-functional teams within different geographies and foster collaboration to achieve results on time.

Your responsibilities will include, but are not limited to:

Launch & Transfer:
• Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches and analytics for transfer.
• Establish overall project strategy and plans including timelines. Put in place site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g. FTEs, batch costs, investments and external costs), strategies and timelines.
• Initiate and own change control for technology transfers.
• Form and lead project teams – set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines and HSE and GMP guidelines are met. Visit technical transfer sites to strengthen the collaboration for a successful transfer of processes and analytical methods.
• Ensure timely availability of technical documentation according to Novartis guidelines. Review Manufacturing Process Transfer Documents (protocol, report) as well as Analytical Methods transfer documents.
• Review key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate).
• Liaise with global technical project manager, transferring site and receiving site functions. Plan and facilitate knowledge transfer from transferring site to receiving site including operator and analyst training.
• Contribute to inspections (Pre-Approval Inspection PAI) readiness.

Project Management Excellence:
• Effectively lead cross-functional teams within different geographies and foster collaboration to achieve results on time.
• Lead the effort across team to generate information from relevant stakeholders to create a project charter, and demonstrate the ability to direct and manage project work on multiple projects.
• Lead the effort across team to generate information from relevant stakeholders to create a project charter, and demonstrate the ability to direct and manage project work on multiple projects.


Minimum requirements

What you'll bring to the role:

• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. Desirable MSc. or equivalent experience.
• 8 years of relevant experience in pharmaceutical manufacturing; comprehensive know how in pharmaceutical technology, project management experience.
• Ability to travel internationally as required.

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!

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.


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.

EEO Statement

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.