Principal Scientist
vor 2 Wochen
8 biosimilars across immunology, oncology and endocrinology are already on the market, and Sandoz Biopharmaceuticals has a leading biosimilars pipeline with additional molecules in various stages of development.
As a Principle Scientist you are responsible for providing high quality analytical data and- expertise to contribute to the future success of our biosimilars development
Your key responsibilities:
Your responsibilities include, but not limited to:
- Planning and organization of outsourced bioanalytical activities, including management of external bioanalytical partner laboratories
- Manage transfers and validation of bioanalytical assays for PK, PD and immunogenicity assessments of biotherapeutics (e.g., ELISA, ECL, largemolecule LC-MS); supervise development and assay optimization
- Support clinical teams to set up the clinical trials by providing bioanalytical input for instance on sample collection and bioanalytical methods
- Coordination of the timely analysis of biological samples from preclinical and clinical studies at external / internal bioanalytical laboratories, including result reporting, data interpretation, data transfer as well as review and/or creation of bioanalytical plans, reports and method SOPs for bioanalytical sample analysis
- Monitor outsourced activities at 3rd party during the course of the studies; support the external lab during troubleshootings
- Support creation of international registration documents and interaction with authorities (where appropriate)
- Participation in project teams as well as presentation of updates / results
- Active contribution to budget forecast, review of contracts and task orders
- Contribution to existing GxP / ISO17025 environment (SOP writing, document preparation and improvement projects)
- May require up to 5% travel
Engagement für Vielfalt & Inklusion
- Novartis ist bestrebt, ein hervorragendes, integratives Arbeitsumfeld und ein vielfältiges Team aufzubauen, das die Patienten und Gemeinschaften, denen wir dienen, repräsentiert._
Mindestanforderungen
What you'll bring to the role:
- Doctoral degree (PhD) with 2-3 years or Master degree with 5 years of work related experience
- Experience in the pharmaceutical industry or CRO in comparable positions
- Scientific experience in bioanalytical techniques for instance ligand binding assays
- Familiarity with regulatory guidelines for bioanalytics (GxP / ISO17025) would be an advantage
- Strong communication and interpersonal skills; demonstrated ability to work in a team and in a fastpaced environment
- Very good knowledge of the English language; German skills an advantage
- Knowledge of relevant software tools preferred (including LIMS systems)
- Good skills in presentation and scientific writing
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? We believe new insights, perspectives and groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying**Imagine what you could do here at Sandoz
Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team's 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.
Division - SANDOZ
Geschäftseinheit
- BioPharma SZ
Land
- Deutschland
Standort
- Oberhaching (bei München)
Unternehmen/Rechtsträger
- Hexal AG
Funktionsbereich
- Forschung & Entwicklung
Art der Stelle
- Vollzeit
Anstellungsverhältnis
- Unbefristet
Schichtarbeit
- Nein
Einstiegslevel
- Nein
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