Senior Expert - Munich, Deutschland - Novartis

Novartis
Novartis
Geprüftes Unternehmen
Munich, Deutschland

vor 3 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung
2023 will potentially see Sandoz become a standalone organization Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally
Together we will shape the future of Sandozare you ready to make a difference?


Your key responsibilities:


Your responsibilities include, but not limited to:

  • Independently manage project activities in the area of analytical characterization (e.g. method-development for characterization of the API, as well as their optimization, validation, -transfer including the know-how and troubleshooting, and ensure their implementations etc.) and contribute to project-specific strategy decisions.
  • Represent own function in technical teams (e.g. global CMC team); perform all project tasks (e.g. design, plan, and support conducting scientific experiments; actively contribute to budget and resource forecast etc.) and responsibilities related to own scope of work, as well as assist leadership team in setting goals, performance evaluations, and development planning discussions with team members.
  • Review and approve analytical results. Ensure integrity of data. Interpret results within relevant context, draw the right conclusions and share with the analytical subteam.
  • Author development reports, study protocols, laboratory procedures, or projectrelated SOPs; write scientific documents for key stakeholders (e.g., other line units, health authorities).

In particular:

coordinate and compile high quality analytical registration documents for HA submissions and write publications, patents; interact with Health Authorities where appropriate; act as technical expert in audits and inspections.


Commitment to Diversity & Inclusion:


  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

What you'll bring to the role:

  • Expert knowledge in the area of analytical characterization of biopharmaceutical products, excellent laboratory and technical expertise (analysis of proteins, antibodies, data evaluation).
  • Thorough understanding of development activities and processes in biopharmaceutical industry; excellent knowledge on relevant regulatory guidelines and very good understanding of regulatory expectations
  • Proficient scientific/technical writing skills (to compile analytical reports and submission documents in English), and excellent presentation and communication skills
  • Fluent in English (oral and written)

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 Sandoz

Commitment to Diversity & Inclusion:


Sandoz is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

Sandoz


Division

SANDOZ

Business Unit
Sandoz Global Development


Country
Germany


Work Location
Holzkirchen (near Munich)


Company/Legal Entity
Hexal AG


Functional Area
Research & Development


Job Type
Full Time


Employment Type
Regular


Shift Work
No


Early Talent
No
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