Pet Advanced Applications Specialist

GE HealthCare; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading healthcare technology company is seeking a PET Advanced Application Specialist in Milan, Italy. The role involves managing technology transfer for PET radiopharmaceuticals, supporting manufacturing sites, and ensuring compliance with regulatory standards. Candidates should have a degree in chemistry and at least 3 years of experience in the pharmaceutical industry. Strong problem-solving skills and a focus on customer engagement are essential. This position offers an opportunity to make significant contributions to precision healthcare.

Competenze

• At least 3 years of experience in the pharmaceutical industry.
• Experience in PET tracer manufacture is essential.
• GMP experience with product quality or supply chain exposure.

Mansioni

• Support multiple PET manufacturing sites.
• Oversee technology transfer of PET radiopharmaceuticals.
• Coordinate with regional field engineers for manufacturing support.

Conoscenze

Problem-solving abilities

Customer focus and engagement

Data analysis and statistics

Scientific leadership

Formazione

Bachelor's degree in chemistry or similar

Descrizione del lavoro

Overview

To provide manufacturing and QC analytical support for GE Healthcare’s network of PET manufacturing partners in EU. Take ownership of key projects associated with both the product process and product materials and consumables, including resolving On-Time Delivery (OTD) issues and providing technical input into new initiatives and delivering key improvements.

GE HealthCares PET Supply Chain-EU is searching for a PET Advanced Application Specialist. This position’s primary responsibilities will organize and facilitate the technology transfer of GE HealthCares licensed radiopharmaceuticals to selected Contract Drug Manufacturing Organizations (CDMOs). This role offers the opportunity to be part of a growing segment within GE HealthCare Pharmaceutical Diagnostics and contribute to the future of precision healthcare. The candidate should expect to work within a fast-paced team supporting a range of priorities throughout the year.

Essential Responsibilities

• Support of manufacturing sites
  • PET radiopharmaceutical manufacturing / QC expert supporting multiple sites and regions for the PET Drugs product.
  • Creating and managing action plans and problem-solving reports to ensure KPIs are met.
  • Technical support and project management for technology transfer projects (working closely with the EMEA PET manufacturing head).
  • Coordinate with GE Healthcare’s team of regional field engineers to ensure a high level of manufacturing support.
  • Review site data to guarantee data can be used in relevant regulatory submissions and filings, and track reliability progress.
  • Detailed analysis of batch data to enable key learnings to be shared quickly across the network for continuous improvement.
  • Develop and improve technology transfer and site qualification documentation.
  • Organize and lead internal and external meetings in support of projects.
  • Oversee transfer of automated manufacture and QC release testing of PET radiopharmaceuticals at external manufacturing sites.
  • Support GMP site setup of PET radiopharmaceutical production and provide site management support as required.
  • Strong customer focus with a good understanding of external partners’ technical capabilities and process workflows, including quality, EHS, facility infrastructure, and equipment setup.
  • Project management oversight of new CMOs to meet project timelines.
  • Ongoing support and project management of CMO operations.
  • Interface with GEHC Quality Assurance on CMO remediation activities.
  • Assist in the design of product development activities and deployment of product updates and enhancements.
  • Review site data to ensure accuracy for relevant regulatory submissions and filings.
  • Travel within European countries or abroad as required to support CMO reliability.
• Technical authority and product lifecycle management
  • Help to develop and maintain product design files for GE Healthcares proprietary PET tracers.
  • Plan and prioritize post-launch development of PET radiopharmaceuticals.
  • Provide voice of customer input to R&D on commercial manufacturing requirements for new PET tracers.
  • Provide support to customers and QA for product complaints related to all PET SC products and consumables.
  • Generate reports, test protocols, and risk assessments to support product and consumables validation and quality decisions.
  • Lead investigations to determine root cause and implement corrective actions and recommendations.

Qualifications / Requirements

• Bachelors degree in chemistry, chemical engineering or similar scientific discipline.
• At least 3 years of experience in the pharmaceutical industry (manufacturing, R&D or technical support).
• Experience in PET tracer manufacture (cyclotrons, chemistry systems, platforms, QC methodology) is essential.
• Key skills must include :
  • Strong problem-solving abilities for remote diagnosis and troubleshooting at manufacturing sites; data analysis and statistics skills are important.
  • Customer focus and engagement: ability to form strong relationships with third-party manufacturing partners; able to work in an international environment.
  • High degree of autonomy; role may be geographically separated from the hiring manager and other team members; provide scientific and technical leadership across global functions.
  • Well-developed internal and external scientific or specialist contacts.
  • GMP experience with product quality or supply chain exposure to regulatory standards.

The successful candidate will have strong knowledge of PET radiopharmaceuticals and prior experience with CMOs, plus high technical expertise in radiochemistry techniques and applications, including automated synthesizers and QC analytical techniques. Strong interpersonal and problem-solving skills and the ability to work independently and lead or contribute as part of the core team are essential for success in product development and commercialization.

The successful individual will also be expected to work independently on behalf of the core team as well as lead, initiate, and/or provide major innovative scientific input in identifying new automated methodologies and radiotracer synthesis opportunities.

For this application we also evaluate candidates who meet the requirements set out in art. 1 or belonging to the protected categories referred to in art. 18 of law 68/99.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: act with humility and build trust; lead with transparency; deliver with focus and drive; ownership; always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by providing the flexibility and support to turn ideas into world-changing realities. Salary and benefits reflect a global organization with opportunity, care, collaboration and growth.

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Additional Information

Relocation Assistance Provided: No

Required Experience: IC

Key Skills: Veterinary Experience, Animal Care, Customer Service, Communication skills, Van Driver, Veterinary Technician Experience, Pet Grooming, Animal Handling, Apache Pig, Hair Styling, Pet Care, Dog Handling

Employment Type: Full-Time

Experience: years

Vacancy: 1