Our client is looking for a senior supply chain professional to design and set up the Supply Chain of a new product in Europe and the US.
Supply Chain Senior Manager - Biotechnologies
Our client is a biotechnology company located in the Geneva area.
Working with the Bioprocessing Development group to take over key relationships and key tasks:
Review and technical approval of commercial drug substance and drug product batch GMP documentation.
Provide Supply Chain input to Quality records (e.g. Change Controls, deviations) for commercial drug substance and drug product manufacturing
Participate in annual Product Quality Review as required by the SOP.
Act as point of contact for issues arising during commercial manufacture, provide technical oversight and act as Person-on-Plant as necessary
Generation of purchase orders and provision of the commercial forecast as required by the MSAs for drug substance, drug product, labelled and packaged final product.
Arrangement of shipment of drug substance and unlabelled drug product to storage location
Liaising with CMO Project Manager with respect to changes in scheduling and batch size requirements (for drug product)
Implementation of supply chain needs with respect to drug substance and drug product manufacturing (e.g. implementation of printing on vial caps)
Perform investigation with Third Parties related to deviations/complaints in the Supply Chain and ensure that appropriate CAPAs are implemented
Support the QA qualification process of Third Parties used in the commercial process and ensure that activities of Technical/Quality Agreements with Third Parties are met for the Supply Chain
Managing the Implementation of the Distribution Plan:
Working with the Business, supply chain consultants, QA, IT and finance to implement the product distribution plan:
Implement the distribution plans for the US and Europe with the selected 3PL vendors, putting in place all GMP and GDP compliant processes, SOPs and Work Instructions to bring the distribution and supply chain into operation in 2018.
Support the creation of the QMS for supply chain and distribution; support the application of appropriate SwissMedic Licenses and Wholesaler Distribution Licenses that are required across Europe.
Liaising with Business and local country staff to embed demand planning processes and translate these into CMO orders.
At least 10 years of previous experience in leading and managing European and US Biopharmaceutical Supply chains to GMP and GDP standards
Previous experience in managing CMOs for biopharmaceutical manufacture
Previous experience in setting up GDP compliant QMS and SOPs for biopharmaceutical supply chain
Track record of achievement working in teams
Excellent relationship management capabilities
Travel will be required in Europe and the US to the CMO and 3PL locations
Thoroughly familiar with operating in a GDP and GMP compliant environment
Good spoken and written English, French and/or German a plus
Our client offers a dynamic and international work environment