Gmp Analytical Expert
Vor 3 Tagen
Major Accountabilities:
- Design, plan, supervise and monitor all activities of assigned pipeline early and late phase projects
- Interpret results, evaluate data, draw relevant conclusions
- Write impactful and wide-reaching process-related SOPs and support generation of registration documents; interact with authorities where appropriate; act as technical guide in audits, inspections or due diligences.
- Communicate, address and solve problems (e.g. deviations and unexpected results from experiments) within own and broader area of responsibility; communicate effectively across organizational interfaces; lead the transfer of know-how or procedures to other departments or external contractors
- Lead assigned functional sub-teams; represent own function in technical and fulfill all project tasks and responsibilities related to the own discipline. Assess and consolidate resource needs and timelines for projects
- Contact person for analytical questions in the field of NBE development, with focus on proteins, including stability studies
**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._
**Minimum requirements**
Ideal Background:
- Technical expert studies with PhD and 6 years relevant industrial experience or equivalent technical education and industrial experience and a known expert in the scientific community
- Proficient in English (oral and written)
- Detailed understanding of development activities and processes in a specific function and broad scientific and strategic background
- Excellent theoretical and scientific knowledge in the relevant area (Biologics)
- Excellent scientific project management and leadership skills
- Excellent knowledge on relevant regulatory guidelines and very good understanding of regulatory expectations
- Demonstrated successful experience with working in interdisciplinary teams, track record of creativity, problem solving and efficiency in projects.
- Ability to lead complex stability challenges and requirements while leading/working in interdisciplinary global teams.
Why Novartis?
769 million lives were touched by Novartis medicines in 2020, 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
**Division**
Global Drug Development
**Business Unit**
TECHNICAL R & D GDD
**Country**
Switzerland
**Work Location**
Basel
**Company/Legal Entity**
Novartis Pharma AG
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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