Senior Expert Downstream Development - Functional Lead

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

Salary Range:

€66,918.00 - €117,800.00

Job Description Summary

Location: Schaftenau, Austria #onsite

Role Purpose:
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.

Job Description

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; 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 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.

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 (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 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)

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: €66,918 to €117,800

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance‑based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Adjustments for Applicants with Disabilities: If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [e-mail] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Skills Desired

Technical Writing