346022BR
Jun 14, 2022
Switzerland

Job Description

6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.

This Senior Bioanalytical Governance, Biological Products position will provide regulatory expertise and scientific leadership in the drug development process of Biotherapeutics including Cell & Gene (C&G) therapies. She or he will collaborate closely with a diversity of internal and external partners. This position will not have oversight across bioanalytical operational, financial, and logistical functions. He or she will act in a sole contributory capacity within the team.

Your responsibilities include, but not limited to:

- Supports and develops a coordinated non-clinical and clinical bioanalytical strategy for all Biologic Product Therapeutic Modalities across the Novartis portfolio (ex. Antibodies, Proteins, bi/tri specifics, ADCs, Cell Therapy, Gene Therapy, CRISPR, etc.).
- Connects with scientists across Novartis, leveraging requirements of pharmacokinetic modeling, immunogenicity assessment, and pharmacodynamic assays, to assure appropriate interpretation and presentation of Discovery, Non-clinical and Clinical Bioanalytical results.
- Provides training and mentoring opportunities to junior associates across the entire spectrum of technical bioanalytical fields.
- Supports Due Diligence exercises, asset integration activities and coordinates strategy and execution with all NIBR functions.
- Reviews Submission Documentation (ex. IND, CTD, ISI) and responses to Health Authority Queries related to Bioanalytical Data and interpretation.
- Captures learnings and themes across projects, leveraging experience from one project to another and ensuring consistency with current industry practices across all therapeutic areas.

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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

• M.S. or Ph.D. with significant and relevant experience in a pharmaceutical company, CRO or related industry.
• In-depth direct experience in regulated Bioanalysis of Biologics across numerous modalities and assay types including strong publication record and active participation in industry forums and discussion groups.
• Familiarity with international regulatory requirements in Bioanalysis.
• Strong communication and writing skills as well as expertise in matrix leadership across pharmaceutical development fields.
• Excellent knowledge of the design, structure, and science of Bioanalytical assays in non-clinical and clinical studies across the development process as well as a good knowledge of closely related functional areas.
• Excellent understanding of the drug development life cycle processes in Biologics from Discovery to Post-Marketing clinical studies.


Why consider Novartis?

766 million. That’s how many lives our products touched in 2021 and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking 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 Novartis

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

We are Novartis. Join us and help us reimagine medicine.
NIBR
Translational Medicine
Switzerland
Basel
Research & Development
Full Time
Regular
No
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346022BR

Sr Bioanalytical Governance, BIO Prod.

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