Senior Technical Project Lead, Biologics CMC

Novartis; Österreich; In loco; EUR 86.000 - 160.000; Tempo pieno

Vantaggi offerti da questo lavoro

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible/hybrid working

14 weeks parental leave

Descrizione del lavoro

Novartis seeks a Technical Project Lead to own end-to-end CMC execution for Biologics Drug Substance programs within the Contract Manufacturing network. You will coordinate Business Development handover through technology transfer, site onboarding, GMP execution and validation, leading diverse teams to meet milestones.

The ideal candidate has 5+ years in biopharma, deep DS process knowledge, and strong customer-facing project leadership.

Competenze

• Bachelor’s, Master’s, or PhD in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related scientific discipline.
• Minimum 5+ years of biopharmaceutical experience with substantial exposure to biologics Drug Substance development, manufacturing, MS&T, technology transfer, or CMC project leadership.
• Strong technical understanding of mammalian and/or microbial DS processes, including upstream and downstream operations, process validation, analytical control strategies, and manufacturing scale-up.

Mansioni

• Act as the technical project lead and single point of contact for biologics Drug Substance programs within the Novartis Contract Manufacturing network.
• Own customer DS projects end to end, from Business Development through technology transfer, site onboarding, GMP execution and validation.
• Lead cross-functional teams across DS development, manufacturing, MS&T, Quality, Regulatory, Supply Chain, Engineering, and Commercial functions.
• Translate contractual obligations and customer requirements into integrated project plans, governance, milestones, deliverables, and resource priorities.
• Ensure robust transfer and manufacturing readiness for mammalian and microbial DS processes.
• Drive delivery against customer commitments for quality, timelines, capacity, cost, and supply reliability, proactively managing risks.

Conoscenze

Biopharma expertise

Project leadership

Customer management

GMP knowledge

Cross-functional leadership

Regulatory awareness

Formazione

Bachelor/Master/PhD in Biotechnology/Biochemistry/Chemical Eng/Life Sciences

Descrizione del lavoro

Novartis seeks a Technical Project Lead to own end-to-end CMC execution for Biologics Drug Substance programs within the Contract Manufacturing network. You will coordinate Business Development handover through technology transfer, site onboarding, GMP execution and validation, leading diverse teams to meet milestones.

The ideal candidate has 5+ years in biopharma, deep DS process knowledge, and strong customer-facing project leadership.