Senior Technical Project Lead - Biologics DS/CDMO

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Schaftenau; Vor Ort; EUR 86.000 - 160.000; Vollzeit

Zusammenfassung

Novartis Pharmaceutical Manufacturing GmbH in Austria seeks a Technical Project Lead to drive end-to-end CMC execution for biologics DS projects. You will lead cross-functional teams across DS, DP, and Analytics, manage risks, and ensure alignment with customer requirements and management.

The role requires strong biologics manufacturing expertise, CMO/CDMO experience, and a customer-focused mindset to deliver on commitments. Hybrid/onsite options may apply.

Qualifikationen

• Minimum 5+ years in biopharma with biologics DS development/manufacturing exposure.
• Strong technical understanding of mammalian and/or microbial DS processes including upstream/downstream operations and process validation.
• Experience leading external customers and delivering against contractual scope.
• Knowledge of GMP, quality systems, change control, deviations, CAPA, and global regulatory expectations.

Aufgaben

• Act as the technical project lead and single point of contact for biologics DS programs within Novartis network.
• Own DS projects end to end from BD and contract handover through tech transfer and GMP execution.
• Lead cross-functional teams across DS development, manufacturing, MS&T, QA, Regulatory, SC, Eng, and Commercial.
• Translate contractual obligations into integrated project plans, governance, milestones, and resources.
• Ensure robust transfer and manufacturing readiness for mammalian/microbial DS processes.
• Drive delivery against customer commitments for quality, timelines, capacity, cost, and supply reliability.

Kenntnisse

Project leadership

Cross-functional collaboration

Customer interface

Risk management

Ausbildung

Bachelor’s/Master’s/PhD in Biotechnology or Life Sciences

Tools

GMP knowledge

Jobbeschreibung

Novartis Pharmaceutical Manufacturing GmbH in Austria seeks a Technical Project Lead to drive end-to-end CMC execution for biologics DS projects. You will lead cross-functional teams across DS, DP, and Analytics, manage risks, and ensure alignment with customer requirements and management.

The role requires strong biologics manufacturing expertise, CMO/CDMO experience, and a customer-focused mindset to deliver on commitments. Hybrid/onsite options may apply.