Mar 31, 2022

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.

What You'll Be Doing:
The Senior Expert will lead and manage all drug product development efforts including but not restricted to:
• Formulation development, stability assessments, and technical management of external vendors. Routinely applies scientific/technical expertise to address complex drug product issues and actively support Technical Development strategies and goals by participating in cross-functional teams. Experience working with Quality systems.
• Knowledgeable of requirements associated with Drug Product for regulatory filings (i.e. extractables & leachables, container closure integrity, in-use stability, etc.).
• As a technical expert within the Technical Development organization, this individual will be accountable for Drug Production development activities for current and future Cell Therapy (CT) projects. 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 drug product considerations and regulatory requirements.
• Additionally, this role will contribute to interdisciplinary technical development initiatives for cell therapy projects. This role is expected to regularly interface with external partners, monitoring outsourced activities and ensuring deliverables according to Novartis standards.
• This role is expected to participate in global teams and contribute to overall development strategies. As a technical expert, he/she will actively participate in several technical forums.
• This role may have the opportunity to hire and manage technical associates in the future.
• The candidate will act as a subject matter expert for drug product considerations for cell therapies; interpreting and communicating results, evaluating data, draw relevant conclusions, and write reports and regulatory documents.

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:
• Advanced degree (MS or PhD) in Cell Biology / Biochemistry or related scientific discipline
• Deep experience in drug product development with particular experience in cell therapies (T-cells, stem cells).
• Strong fundamental knowledge of cell biology, immunology and existing technologies 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.
• Fluent in speaking / writing in English

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.

Global Drug Development
Cambridge, MA
Research & Development
Full Time
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Sr Expert, Science & Technology (Cell Therapy Formulation Development)

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