Senior Expert

329726BR
Oct 12, 2021
USA

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently!

The Senior Expert, Cell & Gene Therapies, will lead and manage all project/network activities while applying their scientific and data analysis expertise to address complex R&D issues! They will actively support Process Science’s strategies/goals by participating in cross-functional teams, provide insight based on thorough data and analysis and coordinate interdisciplinary projects; all while developing long-term strategies on advanced science and technologies!

Your responsibilities include, but are not limited to:

As a key member of the Process Sciences group, this individual will be accountable for data analysis to support process and analytical development activities for current and future Cell Therapy (CT) programs.
Give to key technical activities including technology transfers (internal and external), manufacturing support, and development of source documents for regulatory filings.
Contribute to interdisciplinary technical development initiatives for cell & gene therapy projects.
Regularly collaborate with external partners, supervising outsourced activities and ensuring deliverables according to Novartis standards.
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.
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. (Supply to risk analyses and/or peer review and process challenge meetings.

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:

Education: PhD or equivalent in Cell Biology / Immunology / Engineering/ Data Science/ Bioprocessing or related sciences.
Minimum of 5 years of relevant experience in process/ analytical 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 experience wrangling, unifying, analyzing and reporting results based on the data acquired during process and analytical development activities.
Consistent track record in utilization of special tools/equipment, lab automation tools and specialized facilities.
Further requirements include standout colleague with strong communication (verbal and written) and an established track record of working effectively in a matrix environment.
Position will be filled at level commensurate with experience.

Desirable requirements:
Deep expertise in the field of process development for cell therapies is critical.
Hands-on interest and experience with respective analytical methods is preferred.
A sound knowledge and practical experience in statistics is encouraged. GMP experience and a strong knowledge of relevant regulatory guidelines (FDA, EMEA, ICH) is preferred.

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
Cambridge, MA
Research & Development
Full Time
Regular
No
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329726BR

Senior Expert

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