Pilot Plant Manufacturing & Technology Transfer Expert

Novartis Pharma Schweiz; Ivrea; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading global pharmaceuticals company in Ivrea, Italy is seeking an experienced candidate for a role that involves providing SME support on manufacturing processes, ensuring compliance with GMP standards, and promoting a quality culture. The ideal candidate will have a strong background in GMP manufacturing and be fluent in English and proficient in Italian. This position offers a chance to be a part of a dynamic team committed to improving lives through innovative medicines.

Competenze

• 2+ years in GMP manufacturing support or 8+ years for lower education levels.
• Strong scientific and technical understanding of pharmaceutical production.
• Quality, compliance, and pharma regulatory awareness.

Mansioni

• Provides frontline SME support on manufacturing including hot-cell operations.
• Manages end-to-end Technical Transfers for RLT assets from development laboratory.
• Partners with QA, QC and Regulatory for audits and maintenence of documentation.

Conoscenze

Fluent in English

Proficient in Italian

GMP manufacturing support

Collaboration skills

Change management

Knowledge of MES and ERP systems

Solid command of office productivity software

Strumenti

MES

SAP

Descrizione del lavoro

Key Responsibilities

• Provides frontline SME support on manufacturing on TRD RLT Pilot Plant, including hot-cell operations, radiolabeling, aseptic handling, and time-critical troubleshooting on the shop floor.
• Design processes for RLT production campaigns to meet short half-life constraints and just-in-time release, ensuring adherence to GMP, HSE/SSE, radiation protection rules, and 5S; performs real-time batch follow-up and technical record review.
• Leads investigations for RLT-specific deviations and complaints, drives RCA and CAPAs; manages change control and inspection readiness, aligns with site and corporate QMs/GOPs, and monitors RLT portfolio KPIs and trends (APQR, CPV/OPV).
• Partners with QA, QC and Regulatory for RLT dossiers and audits; maintains GMP documentation and master records for radionuclide precursors, conjugates, and final drug product.
• Drives Operational Excellence for RLT: cycle‑time and yield improvements under decay constraints, 5S in controlled areas, data analytics and control charts; defines technical needs, URS, and functional specs for manufacturing suites in collaboration with Engineering.
• Manages end-to-end Technical Transfers for RLT assets from development laboratory and across sites: recipes/sequences for synthesis and labeling equipment, manufacturing instructions, equipment and process qualifications, technical batches, OPV, change control, and site readiness.
• Promotes Quality, HSE, and radiation safety culture; enables upskilling of operators and technicians in RLT-specific procedures; ensures effective communication of technical, quality, HSE, and radiation impacts. Manage manufacturing documentation life‑cycle.
• Aligns all activities with the RLT portfolio strategy and timelines, ensuring manufacturing readiness, inter‑site coordination, and process innovation to support clinical and commercial RLT programs.

Essential Requirements

• Language: English fluent; Italian proficient.
• Experience: 2+ years in GMP manufacturing support/technical roles; or 8+ years in field for lower education levels.
• Strong scientific and technical understanding with rapid grasp of pharmaceutical production processes. Radio‑pharma knowledge/experience would be a plus.
• Quality, compliance, and pharma regulatory awareness.
• Team player with strong collaboration, negotiation, influencing, and persuasion skills.
• Change management, adaptability, and resilience under pressure.
• Knowledge of MES and ERP systems (e.g., MES, SAP) and related manufacturing IT.
• Solid command of office productivity software.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You will receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network