Scientific Advisor – Drug Substance Project Lead (d/f/m)

About the role

Sandoz, a global leader in biosimilars and generic medicines, is looking for a Scientific Advisor – Drug Substance Project Lead (d/f/m) for its Biopharma Technical Development team, based in Ljubljana. The role combines technical expertise in drug substance (DS) process development, process transfers and process characterization with project management experience, supporting the growing pipeline of biosimilars.

Key responsibilities

• Lead DS project activities, including technical meetings and coordination between functional experts, team leaders and project management.
• Lead process transfers to and from external partners for clinical manufacturing.
• Act as a DS expert supporting development projects at partners and in audits, inspections and due diligence.
• Report project achievements, issues and risks, including risk mitigations, to stakeholders in time.
• Lead or support root cause investigations.
• Write high-level development documents, review submission documentation, respond to regulatory questions and deficiency letters, and lead team preparation for regulatory audits.
• Contribute to long-term strategy and continuous improvement of the platform, manuals and global initiatives related to biosimilar drug substance development.

Required profile

• Master's or doctoral degree in a relevant natural science such as molecular biology, chemical engineering, biochemistry or biotechnology.
• At least 8 years of experience in early and late phase technical development of biologics/biosimilars, with a background in cell line development, USP and/or DSP development.
• Fluent spoken and written English.

Required skills

• Project and people management skills.
• Technical expertise in drug substance process development, process transfers and process characterization.

What we offer

• Permanent contract with a 6-month probation period; expected 40-hour week.
• Pay range of EUR 71,920 - 107,880 gross per year, depending on level, qualifications and experience.
• Annual performance bonus (STI), vacation allowance and Christmas bonus.
• Voluntary additional pension scheme fully covered by the employer, collective life and accident insurance, and a hybrid work environment.