Supply Chain Manager - Milano, Italia - Fondazione Telethon ETS

Fondazione Telethon ETS

Azienda verificata

Milano, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Telethon is a major Italian charity focused on rare genetic diseases.

Founded in 1990, its mission is to advance biomedical research towards the cure of rare genetic diseases otherwise neglected by major public and private investments.

The ultimate goal is to make therapies available to all patients in need._

Posizione:

This position is responsible for developing integrated commercial and clinical supply chain to ensure the delivery of autologous gene therapies to the patients.

The Supply Chain Manager is responsible to manage the external CDMO responsible for the commercial and clinical DP manufacture.

In this role, he/she consistently assures appropriate capacity planning by communicating and coordinating between the clinical sites, by managing starting and critical raw material requirements, planning and controlling its inventory, warehousing and shipping to ensure supply continuity.

A Supply Chain Manager will have a full understanding of Project Management and Supply Chain Management relative to commercial and clinical Supplies.

Areas of responsibility will include sourcing, inventory control and forecasting, cold chain distribution of the starting materials, key reagent/s and drug products, directly or through Third Party CDMO and maintaining strict compliance with national and international regulation and Cells and Tissue legal requirements and cGMP standards at all stages of the supply chain.

He/She will be responsible for the technical oversight of any tech transfer. He/She will also be responsible for linking the supply chain with the internal financial and legal department.

Responsibilities

Manage all the customer care activities related to commercial products and related to products under registration phase
Manage all the customer care activities related to the investigational medicinal products (i.e., clinical trial, Hospital exemption, compassionate use, other early access schemes)
Manage all aspects of supply chain including receiving orders for the commercial drug product, interact internally with legal and finance and manage capacity planning and treatment planning up to shipping and delivery to the clinical center
Coordinate maintenance of the qualification of the clinical centers when the DP is to be administered.
Support Legal in negotiating supply agreement for commercial products and its related quality/technical agreements
Having indepth knowledge on the different reimbursement paths for the commercial products (i.e., Italian National Health System, EU crossborder provisions and private setting) for direct/indirect impact on treatment funding/risksharing conditions to be flagged to finance upfront when a patient is identified for treatment.
Support Legal and Business Development in negotiating Service Agreements with external CDMO for the DP, starting and raw materials supply (after supplier selection and qualification)
Manage technology transfer with the external CDMO (i.e., site manufacturing change for a commercial product)
Manage production planning, patient treatment schedules, budgets and timelines, in collaboration with internal functions and external CDMO
Establish and manage strategic sourcing of raw materials, manage all purchasing, shipping, storage, inventory control and forecast of raw materials (direct purchase for critical reagent/s, if needed), starting materials (i.e., plasmids and cell banks), artworks, "bollino del poligrafico" and drug products directly or playing oversight on external CDMOs, while adhering to cells & Tissue legislations, cGMP quality standards and internal procedures
Manage, in collaboration with the CMC Regulatory Affairs and Quality Assurance Unit, vendor oversight, relationships and selection related to DP supplies and starting/raw materials
Work closely with CMC Regulatory Affairs and Quality Assurance Unit and the technical internal Depts to identify new technical and regulatory requirements
Identify supplier performance gaps and develop action plans to achieve desired performance levels.
Identify and mitigate areas of risk with supplier and vendors
Support the CMC Regulatory Affairs and Quality Assurance Unit in the management of quality assurance tasks related to deviations, CAPAs, change control related to supply activities
Support business development function in any selling/borrowing contracts for starting/raw materials and material compliance provisions (GMP docs, stability data)

Requisiti:

Qualifications

Minimum MS Degree degree,preferred in scientific disciplines
Minimum 57 years of experience in procurement of biological raw and starting materials for biopharmaceutical based GMP manufacturing operations
Experience with CMC activities is a plus
Must have proven inventory and production planning experience
Proven ability in use of informatic supply chain tools
Excellent English oral and written communication
Demonstrated analytical and problem resolution skills