Senior Expert - Device Project Leader - Combination Product Portfolio

Job Description Summary

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

You’ll receive: You can find everything you need to know about our benefits and rewards 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 as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €65,605.54 EUR/year (on a full-time basis). The actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job-sharing models and support flexible and remote working where possible.

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

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 disabilities.austria@novartis.com 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