349385BR
Jul 21, 2022
Germany

Job Description

1996! In this year Sandoz initiated the world’s first biosimilar development program. The exciting field of analytical characterization deals with the analysis of the physicochemical properties of our therapeutic proteins and is part of the global Novartis Technical Research and Development (TRD) department. We focus on the analysis of our biosimilar products and exciting new biological entities, which we support from early development until market entry. You will be supporting the characterization of DS / DP through various project phases from clone selection to process characterization, method transfers, comparability studies, similarity and submission. A wide range of analytical methods and interesting strategic decisions shape your mission. Center of all our activities is the cooperation of all team members and the contribution of each individual.

Are you ready to join a team of motivated, multi-national scientists in Oberhaching? Curious about working in a brand-new lab facility in Holzkirchen as of Q3 2023 onwards? We are looking forward to receiving your application as Senior Expert Science & Technology / Characterization Analytical Expert (d/f/m)

Your responsibilities:
• Represent own function in technical teams (e.g. global CMC team); independently manage project activities in the area of analytical characterization (e.g. design, plan, interpret and report results of scientific experiments for the preparation and timely delivery of API development; method-development for characterization of the API, as well as their optimization, qualification, -transfer including the know-how and troubleshooting, and ensure their implementations etc.; actively contribute to budget and resource forecast). Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall strategies and goals.
• 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.
• Prepare protocols, scientific reports, laboratory procedures, or project-related SOPs; write scientific documents for external partners (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, inspections, and etc.


Diversity & Inclusion / EEO

Novartis is 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:
• Science degree with Ph.D. in biotechnology, chemistry or other natural sciences and a minimum of 6 years relevant experience in the biopharmaceutical industry
• Expert knowledge in the area of analytical characterization of biopharmaceutical products, excellent laboratory and technical expertise (analysis of proteins, antibodies, data evaluation). Experience for Analytical Project Management is a plus
• 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 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.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

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.


Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
TECHNICAL R & D GDD
Germany
Oberhaching (near Munich)
Research & Development
Full Time
Regular
No
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349385BR

Senior Expert Science & Technology (d/f/m)

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