Objective Oversight of the technology transfer of a blockbuster status injectable product from in-house production to a qualified contract manufacturing organization while changing from a
Objective Providing GMP compliance oversight to the process scaling-up and validation of a complex biosimilar manufacturing by a qualified contract manufacturing organization, up to Marketing
Objective Selecting and qualifying a primary and secondary manufacturing service provider for the transfer of the in-house developed biotech drug candidate, suitable for supplying clinical-grade
Objective Creating an in-house GMP-compliant manufacturing capability for a small biotech startup in order to fully leverage the technological platform developed by the firm Outcome
Objective Due to the discontinuation of the related range of activities by the historical CMO, transfer of a portfolio of injectable emergency medicines to another
Objective Act as interim head of a fully integrated PDS unit within the premises of a leading European sterile manufacturing CMO Outcome P&L level management
Objective Prepare and handle the FDA inspection of a fine chemicals manufacturing site, where one of the site legacy products had been the object of
Objective Provide technical and compliance support on-site during critical steps of the pre-PPQ and PPQ runs of a complex and highly innovative synthetic active pharmaceutical
Objective Provide scientific, manufacturing and compliance support to the pharmaceutical development group of a traditional mid-sized pharmaceutical company developing an innovative complex synthetic molecule formulated
Objective Manage the complete network of external service providers for drug substance and drug product process development and manufacturing as well as analytical services; drafting
Objective Provide scientific and industrial rationale for the innovative character of the patent claims challenged by a potential generic competitor Outcome Writing of several expert
Objective Provide a detailed business case for the operational capability (including estimated profitability) of a contract manufacturing organization on behalf of a pharmaceutical group looking