Senior Expert Science & Technology

Novartis

Pharmaceutical Industry

6336 Schaftenau, Tirol - Österreich

Senior Specialist / Project Manager

Hybrid

Experteer Overview

In this role you guide Extractables and Leachables strategies across the drug development lifecycle, collaborating with global cross-functional teams to inform scientific decisions. You will shape analytical and regulatory approaches, drive data-driven risk assessments, and advance testing strategies to support safe, high-quality medicines. Your work spans analytical chemistry, materials science, and regulatory innovation, contributing to Novartis’ mission to reimagine medicine. You will be a scientific partner across projects, delivering impactful technical and regulatory documentation.

Compensation / Benefits

flexible and hybrid working options
14 weeks paid parental leave
insurance plans
retirement plans
wellbeing resources
global recognition programs

Responsibilities

Lead Extractables and Leachables strategies and risk assessments across complex drug development projects
Serve as the scientific expert and primary contact for multidisciplinary project teams
Design and oversee Extractables and Leachables studies with internal laboratories and external partners
Interpret analytical data, identify trends, and provide scientifically sound recommendations
Author and review technical documentation, assessments, and regulatory submission content
Drive cross-functional collaboration to solve complex scientific and operational challenges
Lead continuous improvement initiatives that enhance testing approaches, workflows, and risk assessment strategies

Key requirements

Advanced degree in Pharmacy, Chemistry, Life Sciences, or related scientific discipline
Strong expertise in Extractables and Leachables assessment within a regulated industry environment
Hands-on experience with advanced chromatographic and mass spectrometry analytical techniques
Proven ability to lead complex scientific projects and manage multiple priorities effectively
Excellent scientific writing skills with experience creating technical and regulatory documentation
Strong communication and collaboration skills with the ability to influence across multidisciplinary teams

Strong communication Collaboration Ability to influence across multidisciplinary teams Extractables and Leachables assessment Chromatographic techniques Mass spectrometry

Description

In this role you guide Extractables and Leachables strategies across the drug development lifecycle, collaborating with global cross-functio…

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