Analytical Project Lead / Fellow (m/w/d)
|Division||Global Drug Development|
|Geschäftseinheit||TECHNICAL R & D GDD|
|Standort||Oberhaching (near Munich)|
|Funktionsbereich||Research & Development|
|Art der Stelle||Vollzeit|
8! That is the number of Biosimilars that we currently have in Germany, gaining market shares and fulfilling the promise of Biosimilars. They are an important element in guaranteeing the future of medical care, enabling more patients access to hightec-preparations. If you want to join us in helping more patients to get access, come an join our team!
•Lead and coordinate the analytical sub-team, handle all project/network activities and represent analytics in the global, multifunctional CMC project team of assigned projects. Assess and consolidate resource needs and timelines for projects, networks. Provide scientific and technical guidance, actively drive knowledge exchange. Develop, mentor and coach Principal Scientists and other Scientific Associates.
•Design, plan, perform/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.
•Review and approve analytical results. Ensure integrity of data. Interpret results within relevant context, draw the right conclusions and share within the team.
•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, inspections or due diligences.
•Write impactful and wide-reaching process/strategy-related procedures or development guidelines and drive their implementation; write excellent scientific reports intended for external partners. 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; may require up to 15% travel
•Actively contribute to budget and resource forecast; ensure cost awareness in all assigned projects and/or networks.
What you’ll bring to the role:
•Technical expert studies with PhD and 6 years relevant experience in the biopharmaceutical industry.
•Excellence in the relevant area (analytical, characterization, laboratory and/or technical tools), broad theoretical and scientific knowledge in other areas (e.g. 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), knowledge of German is a plus
•Proficient scientific/technical writing skills and excellent presentation skills
•Independent, thorough and reliable working style
•Demonstrated successful experience with working in interdisciplinary teams, strong record of creativity, problem solving and productivity in projects.
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Join us, and help reimagine access to medicine.
Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
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