Analytical Project Lead

vor 7 Monaten

Munich, Deutschland Hexal AG Vollzeit

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz

**Your Key Responsibilities**:
Your responsibilities include, but not limited to:

- Lead and coordinate the analytical sub-team, manage all project/network activities and represent Analytical Development in the global, multifunctional CMC project team of assigned projects. Assess and consolidate resource needs and timelines for projects, networks.
- Coordinate and compile analytical registration documents for HA submissions and, potentially, write publications, patents; interact with Health Authorities where appropriate; act as technical expert in audits, inspections.
- Design, plan, supervise and monitor all analytical activities of assigned teams/projects (including characterization of the API, method-development, -transfer and -validation, specification setting, release and stability testing, know-how transfer, etc); multitask; understand and meet customer needs.
- Write process/strategy-related procedures or development guidelines and drive their implementation; write scientific reports intended for external partners.
- Ensure integrity of data. Interpret results within relevant context, draw conclusions and share within the team.
- Actively contribute to budget and resource forecast; ensure cost awareness in all assigned projects and/or networks.
- Communicate, address and solve problems within own and broader area of responsibility; communicate effectively across organizational interfaces i.e. project-/program-management; line functions etc.
- Lead the transfer of know-how or procedures to other departments or external contractors, including troubleshooting and on-site training.
- Provide scientific and technical guidance, actively drive knowledge exchange. Develop, mentor and coach principal scientists and other scientific associates.
- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**What you’ll bring to the role**:
Essential Requirements:

- Technical expert studies with PhD and at least 6 years relevant experience in the biopharmaceutical industry.
- Excellence in the relevant area (analytical, characterization of biomolecules, laboratory and/or technical tools), broad theoretical and scientific knowledge in other areas (e.g. biotech manufacturing, pharmaceutical)
- Excellent scientific project management and leadership skills
- Excellent knowledge on relevant regulatory guidelines and very good understanding of regulatory expectations
- Fluent in English (oral and written)
- Proficient scientific/technical writing skills and excellent presentation skills
- Demonstrated experience with working in interdisciplinary teams, strong record of creativity, problem solving and efficiency in projects.
- Independent, thorough and reliable working style

**Why Sandoz?**
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

**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.

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

**Join our Sandoz Network**:
Sandoz

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