Team Lead, Cell Process Development

326520BR
Aug 31, 2021
USA

Job Description

6! The number of Cell & Gene therapy projects waiting for a new innovative Team Lead, Cell Process Development to apply advanced cell process technologies and to define control strategies to unlock the next breakthrough in innovative medicines for patients in need.

As a key member of the Process Sciences group this individual will be accountable for the establishment and management of T-cell proliferation process development for cur-rent and future Cell Therapy (CT) projects. He/She will contribute to key technical activities including technology transfers (internal and external), manufacturing support, and development of source documents for regulatory filings. Deep expertise in the field of process development for cell therapies is essential.

What you will be doing;

•This role will contribute to interdisciplinary technical development initiatives for cell & gene therapy projects. This role is expected to regularly interface with external partners, monitoring outsourced activities and ensuring deliverables ac-cording to Novartis standards.
•This role is expected to coach global team members, participate in global teams and contribute to overall development strategies. As a leader of the process development activities, he/she will actively participate in several technical forums.
•This role may have functional reporting responsibilities for approximately 1-3 people.
•The candidate will act as a subject matter expert for cell therapies projects, interpret and communicate results, evaluate data, draw relevant conclusions and write reports and regulatory documents. (Contribute to risk analyses and/or peer review and process challenge meetings.
•Lead and manage all project/network activities and apply scientific/technical expertise to address complex R&D issues and actively support Process Science’s strategies and goals by participating in cross-functional teams.
•Lead scientific programs; coordinate interdisciplinary projects and teams. Develop long-term strategies on advanced science and technologies

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 will bring to the role;

•PhD or equivalent in Cell Biology / Immunology / Bioprocessing or related scientific field.
• >7 years of relevant experience in process and medium development for
processing for primary cells (T-cells, stem cells) for autologous and/or allogeneic cell production is strictly required.
•Strong fundamental knowledge of cell biology, immunology and existing cell culture process technology is expected. Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities. Hands-on interest and experience with respective analytical methods is preferred.
•A sound knowledge and practical experience in statistics is expected. GMP experience and a strong knowledge of relevant regulatory guidelines
(FDA, EMEA, ICH) is preferred.
•Further requirements include team player with strong communication (verbal and written) and an established track record of working effectively in a matrix environment.

799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
TECHNICAL R & D GDD
USA
East Hanover, NJ
Technical Operations
Full Time
Regular
No
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326520BR

Team Lead, Cell Process Development

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