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Senior Analytical Expert (GMP-AE)

GMP
Inspections
SOPS
Problem Solving
Biologics
Regulatory
Analytics
Description:

This is a temporary contractor opportunity at Novartis 

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! 

 Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit.

 Ready to work with/through Magnit at Novartis? Please read on... 

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

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.

Workload: 100% (40 hours per week)
Role type: Onsite
Estimated start date: February 2025

Why Novartis:  Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture 

Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. 

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network 

Accommodation: If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com 

QUALIFICATION/ LICENSURE :
  • Work Authorization : Other valid work visa
  • Preferred years of experience : 6+ Years
  • Travel Required : No travel required
  • Shift timings: 9 AM to 5 PM
Job Location Basel, Basel-Stadt
Pay CHF 59.00 - CHF 71.00 Per Hour
Contract Duration 18 month(s)