Associate Expert Drug Supply

Novartis; Ivrea; On-site; EUR 30,000 - 56,000; Full time

Job summary

Novartis AG in Ivrea, Italy is seeking a GMP-driven professional to support the production, packaging and shipping of sterile radiopharmaceuticals. You will work in shifts according to internal rotation plans and ensure compliance with HSE, EU GMP, and regulatory requirements.

The role emphasizes material handling, documentation, quality systems, and collaboration with the Production Supervisor and Qualified Person.

Qualifications

• Technical/Scientific background at high school is mandatory.
• University degree in Science is desirable (Pharmacy/Chemical Engineering or Pharmaceutical Technology preferred).
• Good understanding of GMP and regulatory requirements.

Responsibilities

• Perform production, packaging and shipping of sterile radioactive drugs.
• Ensure compliance with HSE, EU GMP Annex 1/Annex 3 and applicable laws.
• Conduct setup, cleaning, and verification in GMP environment.

Skills

SCADA

HMI

Office software

Education

High School technical/scientific background

University degree desirable

Tools

SCADA

HMI

Job description

Carry out the production of radiopharmaceuticals according to GMP rules and approved SOPs. The role foresees working in shifts including morning and afternoon work according to an internal rotation plan.

#LI-Onsite

Location: Ivrea, Italy

Relocation Support: This role is based in Ivera, Italy. Novartis is unable to offer relocation support: please only apply if accessible.

About the Role

Major accountabilities:

• Work in shifts, is responsible to perform the necessary activities for the preparation, production and packaging for shipping of sterile radioactive drugs
• Execute all assigned activities in compliance with internal procedures (HSE, EU GMP Annex 1 / Annex 3, others) and in compliance with applicable laws and regulations
• Perform routine setup and cleaning, microbiological verification of pharmaceutical areasand equipmentand all areas of the Plant with a need for periodic cleaning activities based on GMP
• Perform the preparation of all raw materials needed for the production (batch related kit preparation)
• According with the Production Supervisor, perform the management of material stocks and waste materials
• Follow the GDP in printing, filling and signing all documents (ALCOA+)
• Promptly report to the Production Supervisor and the Qualified Person and/or the HSE Manager any deviation and/ or out of specification detected during the production process
• Perform logistics activities (transportation and documentation related) about the incoming of materials, refilling of the stock areas and packaging materials for shipping.
• Perform activities related to waste management (transportation and documentation related) for radioactive waste
• Support external specialized personnel in carrying out ordinary and extraordinary maintenance/qualificationactivities
• Collaborate with the Production Supervisor to the training of new personnel
• Support the site quality system by providing input from the production area and sustaining the continuous improvement of the facility
• Observe all safety requirements (D.Lgs. 81/08; D.lgs 101/95, Global and local HSE SOPs), GMP regulations (AIFA, FDA), and housekeeping practices while performing duties.
• Provides continuous feedback and is the point of contact for generating improvements and changes aimed at optimizing the quality and efficiency of production processes.
• Responsible for performing technical tests and supporting the qualification and validation phases of processes and products.
• undefined

Education & Qualifications

Technical/Scientific background/education (High School) is mandatory

University degree in Science is desirable, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent job experience.

Languages

• Italian (Local Language): proficient

Experiences

• Minimum 2 years experience in GMP manufacturing support / technical role
• Previous experience in sterile injectable pharmaceutical companies (radiopharmaceutical experience is desirable)
• Good scientific and technical understanding
• Team player with strong team spirit
• Change management, adaptability, ability to work under pressure
• Good understanding or capacity to quickly understand production processes
• Quality and compliance skills
• Good understanding of regulatory requirements across multiple health authorities

Technical / Functional Skills & Knowledge

• Good working knowledge/understanding of typical manufacturing IT system (SCADA, HMI etc)
• Good office software applications

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role:€30,200 to€56,000

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering:

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph

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

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl