Company Description
Gnosis by Lesaffre aims to raise the standard of human health and build a world where proactive health solutions empower people to live longer, happier lives.
By exploring the world of microorganisms, we tap into nature’s biological processes to develop solutions that address pressing health challenges while promoting positive impact on both human and planetary health.
Together with nutraceutical and pharmaceutical brands, we develop revolutionary products that help their customers thrive.
Our vision is a future where health is proactive, solutions are sustainable, and the timeless wisdom of nature guides every step forward.
Think like Nature to Raise human health.
Job Description
At Gnosis, a Lesaffre subsidiary, we are committed to human health and nutrition with the ambition to better nourish and protect the planet. Our Substantiation Science team is looking for a passionate Clinical Trial and Supply Coordinator to join our Substantiation team within Scientific Affairs department.
As a Clinical Trial and Supply Coordinator, you will be responsible for planning, coordinating, and overseeing the execution of investigational product supply and distribution for Gnosis' clinical studies. You will act as the central point of contact between the Substantiation team, other cross-functional production team within Gnosis and CMOs to ensure the timely availability of clinical materials and adherence to all regulatory requirements. Additionally, you will provide support for clinical study management activities, contributing to the successful delivery of Gnosis' clinical programs.
The Clinical Trial and Supply Coordinator will report to the Substantiation Director with close interactions with the Clinical Project Manager.
Activities
Clinical Supply Execution
- Planning and translation of study requirements into operational supply and distribution plans
- Coordinate the clinical squad to define and plan investigational product supply strategy
- Oversee packaging, labelling, QP release, distribution, returns/destruction of the investigational product
- Act as supply chain owner for the investigational product (study set up, manufacturing plan, shipment, product assignment)
- Support demand forecasting and supply planning for investigational product
Vendor & CMO Management
- Act as the point of contact for CMO day-to-day coordination and deliverable tracking
- Support CMO communication and product technical specification alignment process
- Monitor manufacturing, packaging, labelling, batch documentation, release and inventory control of the investigational product
- Manage IP distribution in partnership with the Supply and Logistics team
Logistics and distribution
- Coordinate clinical batch production, QC, stability sample and shipments
- Serve as POC for clinical site shipment and query resolution
- Ensure adherence to GMP, GCP and import/export requirements
Cross-functional collaboration
- Act as the interface between CMO, CRO and internal cross functional teams
- Align with Regulatory, Quality, Logistics and Formulation teams on project progress and ensure execution of plans to ensure product readiness
- Supports cross-functional resolution of risks to clinical product manufacturing and supply
Clinical Study Management Support
- Contribute to clinical trial with study planning and execution
- Support study start-up activities (e.g. contracts, regulatory submissions)
- Maintain study trackers and dashboards
- Organize meetings, agendas and minutes
- Maintain Sponsor essential documents and support inspection readiness
Qualifications
- Degree: Bachelor’s or master’s degree in Pharmacy or Pharmaceutical chemistry or a life-science related field with 2-4 years of experience in a related supply chain or clinical supply role
- Functional experience in clinical supply manufacturing, labelling, packaging and supply (Preferred)
- Experience in clinical trial operations
- Strong expertise in project management and use of project management tools.
- Strong organizational skills and attention to detail
- Ability to manage timelines under pressure
- Good problem-solving skills
- Proficiency in English is essential, knowledge of another global language is an asset
- Travel Expectation: 10-20% of the time
Additional Information
- The job is based in Desio (MB) - Italy
- Permanent Contract, Full-Time
- CCNL Chimico Farmaceutico
- Possible Smart-Working after Probation Period
- Be part of a growing company
- Work in a dynamic international environment
- We promote a sense of fulfilment with a genuine mission: nourish and protect the planet, and Raise Human Health.
- An opportunity to work in a real international environment.
At Lesaffre, diversity is a strength that enriches our culture and our teams. We are committed to offering you a work environment where you can thrive, regardless of your background, gender, age or abilities. We encourage all applications, as we believe that diverse perspectives strengthen our ability to innovate and meet the challenges of tomorrow.
