HEXAL AG

Principal Scientist (d/w/m) limited contract

Holzkirchen
Befristeter Vertrag
Vollzeit

Sandoz is a global leader in generic pharmaceuticals and biosimilars and a division of the Novartis Group. Our purpose is to reimagine medicine to improve and extend people’s lives through the use of innovative science and technology.

Verantwortungsgebiet

limited for 2 years

1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities 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 toward the future, at the same time it becomes also the right step up in your career within clinical development!

Your responsibilities:
Your responsibilities include, but not limited to:

• Independent management and administration of all project activities in the field of analytical characterization and contribution to project-related, strategic decisions and financial planning within the project responsibility
• Lead assigned functional analytical sub-teams; Representation in technical teams (e.g. global CMC team); Fulfillment of all project tasks and responsibilities in relation to own area of responsibility, as well as, support of the management team in setting goals and performance evaluations of team members.
• Independent interpretation and presentation of results, data evaluation and drawing up the relevant conclusions; Carrying out complex tasks without having established procedures. Review and approval of raw data generated by others.
• Development, optimization, validation, application and transfer of analysis methods, as well as the monitoring of all scientific and technical characterization activities of the assigned projects
• Creation of protocols, scientific reports, laboratory procedures or process-related SOPs; Writing of scientific documents for external partners (e.g. other line units, authorities). In particular: Creation of individual chapters of approval documents and, if necessary, direct interaction with authorities.

Qualifikationen

What you’ll bring to the role:

• Minimum: Completed degree with ideally a PhD in biotechnology, chemistry or other natural sciences and at least 2 years of relevant experience in the biopharmaceutical industry, or a Master of Science with 6 years of relevant experience.
• Excellent knowledge in the field of analytical characterization of biopharmaceutical products, laboratory and technical expertise (analysis of proteins / antibodies, data evaluation). Theoretical and scientific knowledge in other areas (e.g. manufacturing, pharmaceuticals).
• Comprehensive understanding of development activities and processes in the biopharmaceutical field, good knowledge of the relevant regulatory guidelines, as well as understanding of regulatory expectations.
• Extensive experience in preparing analytical reports and regulatory dossiers in English and excellent presentation skills
• Strong background in the requirements and activities related to the analytical characterization of biopharmaceutical projects. Desirable: Late-stage project experience / interaction with regulatory authorities / proven contribution to relevant document submissions
• Business fluent language skills in English

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.