Senior Expert Science & Technology (Process Analytical Sciences)

Novartis

Pharmazeutische Industrie

6336 Schaftenau, Tirol - Österreich

Senior Fachkraft / Projektleiter

Experteer Overview

In this role you will lead analytical development activities for DS and DP in a multidisciplinary team developing new biologics. You will apply Quality by Design principles, interpret complex analytical data, and drive efficient collaboration with internal teams and external partners. You’ll oversee in-house and external analytics, support regulatory submissions, and contribute to digitalization initiatives that improve study speed and data integrity. This position offers the chance to shape late-stage biologics programs and work across cross-functional teams in a high-impact environment.

Verantwortungsbereiche

Lead analytical development activities within the process analytical sub-team and coordinate project work
Define physicochemical analytical strategies for DS, DP, and intermediates using QbD
Interpret results and apply data/digital tools to improve efficiency
Lead or support root cause investigations and issue resolution
Monitor progress and provide expert input in sub-team meetings
Oversee internal and outsourced analytical work to meet timelines
Prepare and review scientific reports; support regulatory submissions and audits
Manage competing priorities, communicate challenges, and resolve complex issues
Contribute to budget/resource planning and ensure timely delivery
Foster strong stakeholder relationships with internal teams and CROs
Promote knowledge sharing and contribute to publications, presentations, and patents
Evaluate new analytical technologies and align with scientific standards
Support ongoing digitalization efforts and ensure data integrity in CMC
Respond to analytical queries during audits/regulatory reviews

Zentrale Anforderungen

University degree in pharmaceutical technology, biotechnology, biochemistry, chemistry, chemical engineering, or related science
At least 3 years (PhD) or 6 years (MSc) in (bio)pharma industry
Advanced knowledge in Analytical Development
Expertise in Biologics DS/DP process development applying QbD
Solid project management skills
Excellent collaboration and communication
Proficiency in oral and written English; German beneficial
Strong proficiency in digital technologies

collaboration problem-solving communication Analytical Development Quality by Design (QbD)Biologics DS/DP process development

Stellenbeschreibung

In this role you will lead analytical development activities for DS and DP in a multidisciplinary team developing new biologics. You will ap…

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