325025BR
Apr 21, 2022
Germany

Job Description

20 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar.

The role is limited till the 31st of December in 2022 and can be performed in full time or in part time.

Job purpose:

The Principal Scientist (d/f/m) Program Management Bioanalytics contributes to establish the bioanalytical and immunogenicity strategy for our biosimilar programs by supporting cross-functional global teams and provides assistance in health authority interactions, audits and due diligence activities.

Your responsibilities :

• Provision of expert knowledge for bioanalytical methods and evaluation of data on PK/PD and immunogenicity
• Support in establishing the non-clinical and clinical strategy for bioanalytics and immunogenicity during the different phases of biosimilar development
• Preparation of scientific reports and documents; assisting with briefing books or registration documents and during interactions with health authorities (eCTD modules; Immunogenicity Risk Assessment)
• Review and interpret results, evaluate data and draw relevant conclusions
• Participate in audits, inspections and due diligence activities where appropriate
• Independently lead and manage projects and handle several activities at a time

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 PhD and a minimum of two years work experience with interdisciplinary teams
• Understanding of development activities and strategic thinking
• Good theoretical and scientific knowledge in the relevant area (e.g. large molecule analytics, immunogenicity)
• Knowledge of relevant regulatory guidelines and understanding of regulatory expectations would be an advantage
• Sound knowledge and experience in laboratory work
• Good scientific/technical writing 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
SANDOZ
BioPharma SZ
Germany
Oberhaching (near Munich)
Research & Development
Full Time
Temporary
No
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325025BR

Principal Scientist Program Management Bioanalytics (d/f/m)

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