Senior Expert - Device Project Analyst (f/m/d)

at  Novartis

SUMMARY

Location: Schaftenau, Austria, Hybrid Working #LI-Hybrid About the Role: The diversity of Novartis’ portfolio and required analytical data packages for drug-device combination products are increasing. If you like both, analytical science and project management, and want to lead the creation of strong analytical data-packages for drug-device combination products, then please apply to join an exciting team!

ESSENTIAL REQUIREMENTS:

• Master or PhD in engineering or functional/chemical/bio analytics or equivalent and minimum 5 years’ experience in pharmaceutical industry in combination product development
• 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, experience with current good manufacturing practice (cGMP) and relevant ISOs.
• Collaborative spirit, self-driven attitude, high level of learning agility
• Fluent in English (oral and writing)

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.

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

KEY RESPONSIBILITIES:

Your responsibilities include, but are not limited to:

• As member of global CMC analytical sub team and device sub team for your project(s) you are contact person & 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); plan resource & budget for your project(s)
• Select testing laboratory in line with resource availability, capability and in/outsourcing strategy, e.g. laboratory of Global Device & Packaging Development (GDPD), Quality Control, Contract Research Organisation (CRO); lead outsourced analytical project activities at CROs and contribute to manage external partnership.
• Own drug-specific analytical methods (AMs) / parameter sheets (PSs), organise and align x-functional inputs (e.g. with Device/Pack Tech); define, organise, document AM/PS validation and transfer.
• Co-shape and co-author x-functional analytical CMC strategies and documents, e.g. drug product and final product stability strategy, protocols and reports; method validation and transfer status summaries, Analytical Specifications (AS); organize input to Justification of Specification (JoS) (from Device/PackTech and Human Factors Engineering (HFE))
• Contribute to and review regulatory documents, support product registrations incl. present at inspections.