Senior Expert - Device Project Leader - Combination Product Portfolio / Senior Expertess - Device Project Leader - Combination Product Portfolio

Job ID

REQ-10056351

Jul 11, 2025

Switzerland

Summary

Location: Schaftenau, Austria

Hybrid Working #LI-Hybrid

Role Purpose: With the increasing diversity of Novartis' portfolio, there is a rising need to drive our drug-device combination product portfolio. We are seeking a Senior Expert - Device Project Leader to join our team in Schaftenau within the Portfolio & Customer Center of Global Device and Packaging Development.

As a Senior Expert - Device Project Leader, you will play a crucial role in the Portfolio & Customer Center, part of the Global Device and Packaging Development (GDPD) team based in Schaftenau, AT. Your primary responsibility will be to guide and manage cross-functional project teams both within and outside of the GDPD. This includes representing GDPD in the CMC sub-teams, leading discussions, gaining support, and securing approval for project strategies and necessary changes.

About the Role

Key Responsibilities:

• Represent GDPD in CMC sub-teams, leading device-related discussions and securing endorsements for project strategies or changes.
• Lead cross-functional project teams as a single point of contact (SPOC) for all device and packaging-related issues.
• Plan, manage, and control project resources, schedules, and budgets.
• Assess and negotiate internal & external resource needs on an ongoing basis, while maintaining a high-quality Design History File for developments and LCM projects until transfer to manufacturing sites.
• Ensure compliance with internal process requirements and current regulations, including Design Control, CMC, FDA combination product regulations, and ISO requirements.
• Contribute to the improvement of process and delivery technology approaches.
• Evaluate suitable device technologies to support various project phases.
• Support internal and external audits concerning packaging and medical device-related matters.
• Assist teams in preparing regulatory dossiers, including documents for medical device/combination product registration and in responding to health authority queries.

Essential Requirements:

• Master's degree or PhD (preferred) in natural science, engineering, pharmaceutical field, or equivalent.
• Minimum of 2-4 years of experience in the pharmaceutical industry, preferably in drug-device combination product technical development, including technical operations.
• Ability to work and lead a cross-functional team in a matrix environment.
• Proven knowledge and track record in project and program planning and execution.
• Understanding and awareness of regulatory guidelines for drug-device combination products, including relevant ISOs and current good manufacturing practices (cGMP).
• Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, and strategic thinking.
• Fluent in English (oral and written); German is beneficial.

You’ll receive: More information about our benefits and rewards is available in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities, and worldwide career possibilities within the Novartis group. In accordance with Austrian law, we must disclose the minimum salary as per the collective bargaining agreement. For this position, the minimum salary is €65,605.54 per year (on a full-time basis). The actual salary will be higher, as we strive to maintain a competitive position in the market while considering your previous experience, qualifications, and individual competencies. We are open to part-time and job-sharing models and support flexible and remote working where possible.

Commitment to Diversity & Inclusion:

Novartis is dedicated to fostering an outstanding, inclusive work environment and diverse teams that represent the patients and communities we serve.

Adjustments for Applicants with Disabilities:

If you require accommodations during the recruitment process due to a medical condition, physical disability, or neurodiverse condition, please reach out to disabilities.austria@novartis.com with your request and contact information. We can provide support, including advice on suitable positions and guidance through all stages of the process. Austrian law allows candidates to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process; please let us know if you wish to request this beforehand.

Why Novartis:

Helping individuals affected by disease and their families requires more than innovative science. It takes a community of dedicated, passionate individuals like you—collaborating, supporting, and inspiring each other to achieve breakthroughs that transform patients' lives. Are you ready to create a brighter future together? Learn more about our people and culture.

Join Our Novartis Network:

If this isn't the right opportunity for you at Novartis, consider signing up for our talent community to stay connected and receive updates on suitable career opportunities as they become available: https://talentnetwork.novartis.com/network

Application Process:

Apply online using the form below. Only applications matching the job profile will be considered.

Division

Development

Business Unit

Innovative Medicines

Location

Switzerland

Site

Basel (City)

Company / Legal Entity

C028 (FCRS = CH028) Novartis Pharma AG

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.