338577BR
Feb 24, 2022
Switzerland

Job Description

>70! The number of development products within the biotechnology platform waiting for a new innovative GMP Analytical Expert. As part of the Biologics Analytical Operations Physico-chemical department, laboratory, you will lead and manage all project activities and apply scientific and GMP expertise to address complex R&D issues within a multifunctional project team.

Major Accountabilities:
• Design, plan, supervise and monitor all activities of assigned pipeline early and late phase projects
• Interpret results, evaluate data, draw relevant conclusions
• Responsible for release and stability testing strategy; subject matter expert for stability and analytical related topics.
• 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

Diversity & Inclusion / EEO

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!
Global Drug Development
TECHNICAL R & D GDD
Switzerland
Basel
Research & Development
Full Time
Regular
No
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338577BR

GMP Analytical Expert (m/f/d)

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