Director Strat Technical Initiatives Bio (d/f/m)

Job Description

2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it's growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role!

Are you ready to make a difference?

Your key responsibilities:
Your responsibilities include, but not limited to:
• To identify and lead strategic technical development projects to deliver impact across the Sandoz biotherapeutic portfolio
• Follow and anticipate new developments in all CMC related fields to achieve and demonstrate analytical similarity
• In close collaboration with other departments (e.g., regulatory policy/affairs/CMC/clinical) ensure the concept of analytical similarity assessment is continuously updated and aligned with overall company’s strategy to demonstrate similarity
• Collaborate with technical development functions to ensure that similarity strategy is at the center of technical development throughout the development lifecycle of a biosimilar program
• Liaise with Regulatory Affairs Biosimilars and contribute to the regulatory advocacy strategy and shape the biosimilar landscape (e.g., participating in advocacy meetings with health authorities, commenting on guidelines from health authorities)
• Foster knowledge sharing and communication between internal/external technical development departments, Regulatory policy/affairs/CMC and Sandoz clinical development

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:
• World leading expertise in biosimilar technical development
• Profound knowledge of analytical similarity assessment
• Extensive experience in biosimilar development through regulatory approval and commercialization
• Ability to lead in a matrix organization
• Strategic thinking

This position is available in 3 different locations: Germany (Holzkirchen), Austria, Slovenia.

Desirable Requirements:
• Min 10 years of experience in biosimilar’s technical development development
• Proven track record of interactions with regulatory agencies on biosimilarity strategy
• Proven track-record of driving technical initiatives from ideation to implementation
• Exposure/competence in Technical/ Manufacturing/ Product Development process in regulated environments
• Profound knowledge of Biosimilars Technical Development is a must
• Experienced in managing a portfolio of projects and managing stakeholders at different levels, including Top management.
• Strong Project and solid Change Management skills
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Strong business awareness and perspective, yet able and willing to work hands-on.
• Entrepreneurial, energetic, can-do attitude

#ORBIT

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