Life Sciences & Technology
| Clinical Research & Clinical Affairs
Location: New Jersey (but assignment will be remote)
Duration: 6+ Months
A Black Diamond client is looking for a CMC consultant to lead the development of a better process and system for tracking CMC changes. This would be one of the several Global Oneness Projects in CMC to define the roles & responsibilities of the different regions develop a risk assessment guidance, optimize technology transfers, etc.
The client has an expansive pipeline and there are a significant number of changes initiated by CMC on a regular basis (ie change in dose, form, manufacturer, process, etc.) for investigational drugs for clinical trials and commercial production. Currently, the changes are tracked on an ever expanding excel sheet, but now need to bring on a database/tracking software to manage & control the release of batches more effectively. For example, if there is a trial in Canada and they need to know if batch 47 could be used/approved, the client needs to be able to in real-time access this information. The company may use a system/module within a system they already use like Veeva Vault or trackwise or may evaluate an off the shelf software but will need to be a cloud-based system that could be used globally with secured connections.
The consultant will need to help manage and drive this program as part of their responsibilities (initially thinking about 60% of their time would focus on this). Would be a strong plus if individual has experience with the process of bringing on/implementing a similar type of system. The rest of the time the consultant will support the CMC teams daily functions and would be a preference on having a drug product and formulation background as this is the missing expertise in the group.