Senior Expert Science & Technology – Downstream Process Development

Location: Schaftenau, Austria #onsite

Job ID: REQ-10065908

Company / Legal Entity: AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area: Research & Development

Job Type: Full time

Employment Type: Regular

Summary

Our Downstream Development team plays a crucial role in the late-phase development and transfer of biopharmaceutical drug substance (DS) processes. We are contributing significantly to bringing innovative biopharmaceutical drugs to the market and are dedicated to leveraging data science and digital initiatives to drive innovation and efficiency.

We are currently seeking a highly skilled and motivated Senior Expert to join our dynamic DSP Development team. In this role, you will be responsible for leading our portfolio pipeline projects in downstream process development. Your expertise will be crucial in supporting our development and submission initiatives, ensuring that our development strategies are aligned with our business goals.

Major Accountabilities

• 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 and perform complex tasks without having established procedures of downstream processes.
• Work according to appropriate standards for quality, ethics, health, safety, environment protection and information security, lead initiatives to ensure continuous improvement; all activities have to be aligned with organizational workflows and procedures.
• 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 Procedures.
• Successful execution of assigned tasks within given timelines at expected quality, right first time and 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.

Skills/Experience

• 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 such as 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 adopt to change with strong communication across organizational interfaces.
• Understanding of regulatory requirements and CMC development processes.
• Ability to work with a cross-functional team in a matrix environment.

Languages

• English required.
• German preferred but not mandatory.

Salary

In accordance with Austrian law, Novartis discloses the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €59,781.96/year on a full time basis. In most cases, the actual salary will be higher, as Novartis strives to maintain a competitive position in the market and considers previous experience, qualifications and individual competencies.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives.

Learn more about Novartis people and culture: https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways Novartis helps employees thrive personally and professionally. Read our handbook