Strategic Analytical Project Lead — Medical Devices

Novartis; Österreich; Hybrid; EUR 71,000 - 86,000; Full time

Benefits offered by this job

Incentive program

Company pension

Childcare facilities

Learning opportunities

Worldwide career possibilities

Job summary

Novartis in Schaftenau, Austria seeks a Senior Expert - Medical Device Analytical Representative to lead the creation of robust analytical data-packages for drug-device combination products. You will be a key contact within the global CMC analytical and device subteams, coordinating tasks from component level to final product for injectables in prefilled syringes and autoinjectors.

The role emphasizes ownership of analytical methods and validation, external collaboration with CROs, and shaping

Qualifications

• Master or PhD in engineering or chemical/bio analytics with 5+ years in parenteral combination product development.
• Proven leadership in global matrix development projects; knowledge of cGMP and ISOs.
• Fluent in English (written and spoken).

Responsibilities

• Coordinate and lead analytical tasks for drug-device combination products across components to final product.
• Select testing laboratories and manage outsourced analytical activities and CROs.
• Own analytical methods and parameter sheets for functional attributes like activation and injection force.
• Contribute to CMC strategies, documents, and regulation-ready reports; support product registrations.

Skills

Combination product development

Project leadership

English proficiency

Education

Master’s or PhD in engineering or chemical/bio analytics

Tools

Minitab

Job description

Novartis in Schaftenau, Austria seeks a Senior Expert - Medical Device Analytical Representative to lead the creation of robust analytical data-packages for drug-device combination products. You will be a key contact within the global CMC analytical and device subteams, coordinating tasks from component level to final product for injectables in prefilled syringes and autoinjectors.

The role emphasizes ownership of analytical methods and validation, external collaboration with CROs, and shaping