Leading Scientist Pharmaceutical Development Biosimilars

Sandoz

Ljubljana, Slovenia

Job Description

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 formulations, technologies and processes that will enable production of high quality biosimilar drug products. We are looking for a Leading Scientist Pharmaceutical Development Biosimilars (d/f/m) with project management experience in drug product formulation development, process development and process transfers for biosimilars.

Your key responsibilities

Your responsibilities include, but not limited to:

Drug product development according to assigned project workpackages and in alignment with project strategy, objectives and timelines;
Leading of Drug Product (DP) development project activities and alignment of activities between functional experts, team leaders, and project management;
Leading of process transfers to/from Manufacturing Organizations for clinical and commercial manufacturing at external and internal partners;
Interpret results, evaluate data and draw relevant conclusions; supervise project-related scientific activities and challenge conclusions made by other scientists;
Act as a technical expert in audits, inspections, alliances and/or due diligence activities as needed;
Contribution to technical 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;
Contribution to long term DP development strategy especially in the filed of process transfers and late phase process development, continuous improvement of DP development platform, development manuals and global initiatives related to development of biologics drug product;
Ensuring compliance of activities with standards in the field of quality (GMP), in the field of ensuring health and safety at work and other Sandoz standards.

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 product development of biologics/biosimilars, ideally experience in the filed of process transfers and late phase process development;
Fluency in oral and written English;
Project management skills.

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