Senior Expert Downstream Process Development - Functional Lead

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Schaftenau; Vor Ort; EUR 67.000 - 118.000; Vollzeit

Benefits dieser Stelle

Hybrid working options

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

14 weeks parental leave

Zusammenfassung

Novartis Pharmaceutical Manufacturing GmbH in Schaftenau, Austria, is seeking a Senior Expert and Functional Lead for Downstream Process Development. You will guide DSP strategies for late-stage biologics, shape purification platforms, manage technology transfers, and mentor teams.

This role offers high-impact science, exposure to global regulatory submissions, and opportunities to integrate automation, AI and data science into development workflows.

Qualifikationen

• Degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Biochemistry, Pharmaceutical Technology or related discipline.
• Significant industry experience in downstream process development.
• Deep expertise in chromatography, filtration and protein purification technologies.
• Strong understanding of CMC development and regulatory expectations.
• Experience with process characterization, filings or technology transfers.
• Ability to translate complex scientific data into development decisions.
• Strong collaboration and communication skills in matrix organizations.
• Experience with statistical and data-driven approaches (e.g., JMP).
• Knowledge of Python, R, SQL, modeling or digital tools is an advantage.

Aufgaben

• Lead downstream development strategies for late-stage biologics programs from process development through submission and commercialization
• Shape purification platforms and drive innovative approaches for chromatography, filtration and process intensification
• Act as Functional Lead for DSP activities across multiple portfolio projects
• Guide process characterization strategies and support global regulatory submissions
• Drive technology transfers to manufacturing sites and external partners worldwide
• Influence future DSP capabilities through automation, modeling, digitalization and AI-enabled development workflows
• Lead troubleshooting and complex scientific investigations
• Mentor colleagues and contribute to a culture of scientific excellence
• Present your work to senior leadership and contribute to publications, patents and external scientific conferences

Kenntnisse

Biotech

Process development

Chromatography

Filtration

Protein purification

CMC development

Regulatory knowledge

Technology transfer

Data analysis JMP

Python/R/SQL

Ausbildung

Degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Biochemistry, Pharmaceutical Technology or related discipline

Tools

JMP

Python

R

SQL

Jobbeschreibung

Salary Range: €66,918.00 - €117,800.00 Job Description Summary Location: Schaftenau, Austria #onsite

Role Purpose:

At Novartis, we are reimagining medicine by transforming breakthrough science into life-changing therapies for patients worldwide. Our Downstream Process Development organization plays a critical role in advancing innovative biologics from late-stage development through global registration, commercial launch, and manufacturing transfer. As we prepare multiple high-impact submissions and launches across a diverse biologics portfolio, we are looking for an experienced Downstream Process Development expert to help define the future of DSP development. This is more than a laboratory role. It is an opportunity to influence development strategies, lead complex programs, drive digital innovation, and help shape how next-generation biologics are developed and transferred into manufacturing.

Job Description

As Senior Expert and Functional Lead, you will provide scientific leadership across key biologics programs and act as a trusted DSP subject matter expert within multidisciplinary development teams.

You will:

• Lead downstream development strategies for late-stage biologics programs from process development through submission and commercialization
• Shape purification platforms and drive innovative approaches for chromatography, filtration and process intensification
• Act as Functional Lead for DSP activities across multiple portfolio projects
• Guide process characterization strategies and support global regulatory submissions
• Drive technology transfers to manufacturing sites and external partners worldwide
• Influence future DSP capabilities through automation, modeling, digitalization and AI-enabled development workflows
• Lead troubleshooting and complex scientific investigations
• Mentor colleagues and contribute to a culture of scientific excellence
• Present your work to senior leadership and contribute to publications, patents and external scientific conferences

Why this role is unique

High-impact science

Work on innovative biologics programs that directly support major clinical and commercial milestones.

Scientific influence

Shape development strategies and key technical decisions across a global portfolio.

Advanced technology environment

Help integrate modeling, automation, data science and AI into downstream process development.

End-to-end development

From laboratory development and pilot scale studies to global technology transfers and commercial manufacturing.

Exceptional visibility

Collaborate with experts across Development, Manufacturing, Quality, Regulatory Affairs, Analytical Development and global manufacturing sites.

What you'll bring

• Degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Biochemistry, Pharmaceutical Technology or related discipline
• Significant industry experience in downstream process development
• Deep expertise in chromatography, filtration and protein purification technologies
• Strong understanding of CMC development and regulatory expectations
• Experience supporting process characterization, filings or technology transfers
• Ability to translate complex scientific data into development decisions
• Strong collaboration and communication skills in matrix organizations
• Experience with statistical and data-driven approaches (e.g., JMP)
• Knowledge of Python, R, SQL, modeling or digital tools is an advantage

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

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.