Senior Expert - Device Project Leader - Combination Product Portfolio

Job Description Summary

Location: Basel, Switzerland
Hybrid Working #LI-Hybrid

Role Purpose:
With the increasing diversity of Novartis' portfolio, the need for driving our drug-device combination product portfolio is also increasing. As such, we are searching for a Senior Expert – Device Project Leader for joining our team in Basel in the Portfolio & Customer Center within Global Device and Packaging Development

In the role of Senior Expert – Device Project Leader, you will be a vital part of the Portfolio & Customer Center within the Global Device and Packaging Development (GDPD) team based in Basel/CH. Your primary responsibility is 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 relevant discussions, gaining support, and securing approval for project strategy and changes.

Job Description

Key Responsibilities:

• Represent GDPD in CMC sub-teams, leading device-related discussions and securing endorsement for project strategy or changes.
• Lead cross-functional project teams, acting 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. Establish and maintain 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 technology to support different project phases.
• Support internal and external audits on packaging and medical device related matters
• Assist teams in regulatory dossiers preparation, including documents for medical device/combination product registration and in responding to health authority queries.

Essential Requirements:

• Master or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent.
• Minimum 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, strategic thinker.
• Fluent in English (oral and writing), German is beneficial

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

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired