Senior Downstream Process Development Lead

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

Benefits dieser Stelle

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

Zusammenfassung

Novartis in Schaftenau, Austria is seeking a Senior Expert to lead downstream development activities for our portfolio. You will drive chromatography and filtration steps, plan experiments, and document results to support development and submissions.

The role requires strong collaboration in a matrix environment, experience in DSP, and familiarity with regulatory CMC processes. We offer hybrid work options and a competitive total rewards package.

Qualifikationen

• Completed studies in Biotechnology, Process Engineering, Biology, Biochemistry, Pharmaceutical Technology, Technical Chemistry, Pharmacy, ideally with several years of industry experience.
• Experience in Downstream Processing, in particular with chromatography systems, e.g. ÄKTA systems.
• Hands-on experience with statistical discovery software (e.g. JMP).
• Proficiency in programming languages such as Python, R, or SQL is a plus.
• Excellent problem-solving skills and the ability to think critically.
• Strong communication and collaboration skills.
• A personality with a can-do mentality and the ability to adapt to change with strong communication across organizational interfaces.
• Understanding of regulatory requirements and CMC development processes.

Aufgaben

• Lead and organize the downstream process development activities for our portfolio pipeline projects.
• Perform chromatography steps, cross flow filtration / tangential flow filtration and other membrane separation methods for purification of recombinant proteins as part of process development and characterization at laboratory and pilot scale.
• Independently plan, organize, perform and document scientific experiments; handle several activities at a time.
• Documentation of the studies in electronic documentation systems according to defined standards.
• Evaluate and interpret results, propose and actively support the design of next experiments; supervise project-related activities.
• Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security; lead initiatives to ensure continuous improvement.
• Generate scientific documents to hand over to internal and/or external partners and support generation of international registration documents under minimal supervision.
• Contribution to technology transfers to internal and external sites and definition of process steering controls.
• Support the organization of the laboratory; generate lab procedures, reports and/or instructions and/or Standard Operating Procedure's.
• Successful execution of assigned tasks within given timelines at expected quality, right first time & right in time.
• Communicate effectively across organizational interfaces; lead troubleshooting and transfer of know-how to other departments or external partners.
• Act as Functional Lead for DSP development projects, participate in sub-teams and contribute to overall TRD strategies and goals and support decision-making.

Kenntnisse

Downstream Processing

Chromatography (ÄKTA)

Data analysis (JMP)

Programming (Python, R, SQL)

Problem solving

Communication

Cross-functional teamwork

Ausbildung

Biotechnology

Process Engineering

Biology

Biochemistry

Pharmaceutical Technology

Technical Chemistry

Pharmacy

Tools

JMP

ÄKTA systems

Python

R

SQL

Jobbeschreibung

Novartis in Schaftenau, Austria is seeking a Senior Expert to lead downstream development activities for our portfolio. You will drive chromatography and filtration steps, plan experiments, and document results to support development and submissions.

The role requires strong collaboration in a matrix environment, experience in DSP, and familiarity with regulatory CMC processes. We offer hybrid work options and a competitive total rewards package.