Senior Expert (m/f/d) - Characterization Analytical Expert

Job Description

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 Sandoz... are 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 sub-team.
•Author development reports, study protocols, laboratory procedures, or project-related 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.

Diversity & Inclusion / EEO

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:

•The ideal candidate has a doctoral degree in biotechnology, chemistry or other natural sciences and 6+ years of relevant experience in the biopharmaceutical industry, ideally in Analytical Project Management;
•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?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 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.

We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

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.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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