Drug substance project lead (d/f/m)

Job Description Summary

Job Description

Sandoz is a global leader in Biosimilars and Generic medicines. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. As Sandoz Global Development Organization, we are responsible for the development and delivery of biosimilar and generic medicines, impacting patients’ lives worldwide.

The role is part of Biopharma Technical Development and will be based in Slovenia. Our aspiration is to be innovative in applying science to develop cell lines, technologies and processes that will enable production of high quality biosimilars. We are looking for a Drug substance project lead (d/f/m) with project management experience in drug substance process development and process transfers for biosimilars.

Your key responsibilities:

• Drug substance development of assigned project workpackages in alignment with project strategy, objectives and timelines.
• Leading of project activities including technical meetings, alignment of activities between functional experts, team leaders, project management.
• Leading of process transfers to/from external partners for clinical manufacturing.
• Act as a technical expert in audits, inspections, alliances and/or due diligence activities as needed.
• Contribution to global project team meetings, timely reporting of project achievements, issues and risks including risk mitigations to project management and line function stakeholders. Leading or supporting root cause investigations.
• Management and/or writing of high level development documents, review of submission relevant documentation, responses to regulatory questions and deficiency letters. Leading of drug substance team preparations for regulatory audits.
• Planning and coordination of development and clinical drug substance supply.
• Contribution to long term strategy, continuous improvement of platform, manuals and global initiatives related to development of biosimilar drug substance.

What you will bring to the role:

• Master or Doctoral degree in relevant natural science such as molecular biology, chemical engineering, biochemistry or biotechnology.
• 5 years of working experience in the field of drug substance development of biologics/biosimilars.
• Fluency in oral and written English.
• Project management skills.

You’ll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), employment at Top SI Employer, Unlimited learning and development opportunities.

Possible job locations: Slovenia (Ljubljana)

We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by October 25th, 2024.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 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

#Sandoz #BioRampUp

Skills Desired