Senior Project Manager - Drug Device Combination Product Analytics (f/m/d)

Summary

Location: Basel, Switzerland,
Type: Hybrid Working #LI-Hybrid

With the increasing diversity of Novartis' portfolio, the need for drug-device combination product analytical data packages is also increasing. As such, we are searching for an Associate Director - Senior Project Manager 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 & 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), with a focus on challenging projects and platforms.

About the Role

Your responsibilities include but are not limited to:
• Leading all analytical tasks of complex device and drug-device combination product projects incl. planning resource & budget and authoring respective analytical documents for functional attributes (e.g. opening, breakloose and extrusion forces, injection time and depth, needle-safety resistance, container closure integrity).

• Selecting testing laboratories in line with resource availability, capability and in/outsourcing strategy; these include the laboratories of Novartis Global Device & Packaging Development (GDPD), as well as Novartis TechOps Quality Control and external Contract Research Organisations (CROs)

• Leading outsourced analytical project activities at CROs and contributing to the management of external partnerships.
• Taking ownership of drug-specific analytical methods (AMs) / parameter sheets (PSs) and organising and aligning x-functional inputs (e.g. with Device/Pack Tech).

• Defining, organising and documenting AM/PS validation and transfer.
• Co-shaping and co-authoring x-functional analytical CMC strategies and documents; This will include drug product and final product stability strategy, protocols and reports, method validation and transfer status summaries and Analytical Specifications (AS).

• Organizing and aligning input to Justification of Specification (JoS) from Device/PackTech and Human Factors Engineering (HFE)

• Leading x-functional overarching initiatives; mentoring (senior) experts
• Contributing to and reviewing regulatory documents, supporting product registrations, presenting to Health Authorities.

Essential Requirements:
• Master or PhD in engineering or functional/chemical/bio analytics or equivalent and minimum 10 years' experience in pharmaceutical industry, including drug-device combination product development
• Profound knowledge in analytical tasks including functional (physical) testing of late phase parenteral drug delivery devices or combination products

• 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)

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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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Division
Development

Business Unit
Innovative Medicines

Location
Switzerland

Site
Basel (City)

Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No