Senior Downstream Development Lead, Bioprocess Innovation

Novartis; Österreich; Vor Ort; EUR 67.000 - 118.000; Vollzeit

Benefits dieser Stelle

Insurance plans

Retirement plans

Wellbeing resources

Hybrid working options

14 weeks parental leave

Zusammenfassung

Novartis in Schaftenau, Austria is seeking a Senior Expert to lead our DSP downstream development portfolio. You will oversee project activities, drive experiments from planning to documentation, and work with cross‑functional teams to ensure high quality, compliant processes for late‑phase drug substance development.

You will contribute to technology transfers, generate scientific reports, and support regulatory submissions while maintaining a strong focus on data integrity, safety, and

Qualifikationen

• Experience in downstream processing and chromatography methods for protein purification.
• Ability to design, plan and document experiments with clear data records.
• Strong communication and cross‑functional collaboration within a matrix organization.
• Understanding of regulatory requirements and CMC development processes.
• English language proficiency; German preferred but not mandatory.

Aufgaben

• Lead downstream process development activities for portfolio projects.
• Perform chromatography steps, filtration and other separation methods at lab and pilot scale.
• Independently plan, organize, execute and document experiments; manage multiple tasks.
• Document studies in electronic systems according to standards.
• Support technology transfers and define process steering controls.
• Generate scientific documents and support regulatory submissions when needed.

Kenntnisse

Downstream Processing

Chromatography systems

JMP

Python

R

SQL

Problem solving

Communication

Cross-functional teamwork

Regulatory knowledge (CMC)

Ausbildung

Completed studies in Biotechnology, Process Engineering, Biology, Biochemistry, Pharmaceutical Technology, Technical Chemistry, Pharmacy

Tools

ÄKTA systems

JMP

Jobbeschreibung

Novartis in Schaftenau, Austria is seeking a Senior Expert to lead our DSP downstream development portfolio. You will oversee project activities, drive experiments from planning to documentation, and work with cross‑functional teams to ensure high quality, compliant processes for late‑phase drug substance development.

You will contribute to technology transfers, generate scientific reports, and support regulatory submissions while maintaining a strong focus on data integrity, safety, and