Associate Director Science & Technology (m/f/d)

Summary

With the increasing diversity of Novartis' portfolio, the need for drug-device combination product analytical data packages is also increasing. Novartis is searching for a Senior Expert - Medical Device Analytical Representative with combination product development experience to lead the creation of strong analytical data packages.

As a member of the global Chemistry Manufacturing Control (CMC) analytical sub team and device sub team for your project(s), you will be the main contact and coordinator for all project-specific analytical tasks related to functional attributes of drug-device combination products at all levels, from component to drug product to final product, especially for injectables like Biologics, Ribonucleic Acids and Radio-Ligands in a prefilled syringe, autoinjector or needle-safety-device.

#LI-Hybrid

Location - Schaftenau, Austria

Key Responsibilities

• Act as contact person and coordinator for project-specific analytical tasks related to functional and mechanical attributes of drug-device combination products at all levels and plan resources and budget for your project(s).
• Select testing laboratories in line with resource availability, capability and in/outsourcing strategy, lead outsourced analytical project activities at CROs and contribute to managing external partnerships.
• Own drug-specific analytical methods and parameter sheets for functional attributes such as activation and injection force, time, volume, sound and needle safety features.
• Define, organize and document analytical method and parameter sheet validation and transfer.
• Co-shape and co-author cross-functional analytical CMC strategies and documents, including stability strategies, protocols and reports, method validation and transfer summaries and analytical specifications.
• Contribute to and review regulatory documents and support product registrations.
• Perform statistical data analysis using tools such as Minitab to generate and justify device-related specifications for clinical and commercial setup.

Essential Requirements

• Master or PhD in engineering or chemical/bio analytics or equivalent.
• Minimum 5 years' experience and strong knowledge in parenteral Combination Product Development or related areas such as Manufacturing, Regulatory or QA.
• Proven knowledge in late phase parenteral analytical development.
• Leadership experience in managing development projects, ideally in a global matrix environment.
• Understanding and awareness of regulatory guidelines for combination product analytics, cGMP and relevant ISOs.
• Collaborative spirit, self-driven attitude and high level of learning agility.
• Proficiency in English, written and spoken.

Rewards

In addition to a market-competitive base salary, Novartis offers 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.

For this position the minimum salary according to the collective bargaining agreement is EUR 78,383.90 per year on a full-time basis. The primary location salary range is EUR 88,300.00 - EUR 164,100.00 per year. The actual salary will be significantly higher depending on previous experience, qualifications and individual competencies.

Novartis is open for part-time and job-sharing models and supports flexible and remote working where possible.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people collaborating, supporting and inspiring each other.

https://www.novartis.com/about/strategy/people-and-culture

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