Head Operations Bioanalytics (d/f/m)

321468BR
Sep 14, 2021
Germany

Job Description

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.

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

• Management and supervision of the bioanalytical operational activities at the site Oberhaching with 5 laboratory teams
• Ensure timely development and validation of bioanalytical PK, PD and immunogenicity assays as well as analysis of serum samples for the support of preclinical and clinical trials
• Represent Clinical Bioanalytics for assigned project internally and externally and provide scientific expertise to the bioanalytical testing as well as strategic planning activities.
• Plan laboratory operation resources according to project priorities
• Ensure timely preparation of SOPs, analytical plans and reports according to GxP/ISO17025
• Support and drive bioanalytical laboratory excellence projects
• Support preparation of scientific documents including registration documents and lead interaction and communication with HA.
• Ensure compliance with legal (e.g. radiation safety, biological safety, worker safety) and regulatory requirements (GxP, ISO17025)
• Professional development of associates.
• Budget planning



Minimum Requirements

What you’ll bring to the role:

• PhD in Natural/Biological Sciences with 10 years + practical experience in bioanalytics and immunology
• Experience in people and operational management
• Experience in bioanalytical assay development and validation (PK/PD and immunogenicity)
• Experience with regulatory agencies/guidelines and industry standards
• Good understanding of GxP, ISO17025
• Excellent interpersonal, leadership and teamwork skills
• German and English fluent in written and spoken




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 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 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.

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
Regular
No
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321468BR

Head Operations Bioanalytics (d/f/m)

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