CMC Project Manager
|Job Title:||CMC Project Manager|
|Contact Name:||Fareen Choudhry|
|Job Published:||July 13, 2016 11:44|
CMC Project Manager required for a Cell Therapeutic company. My client is a leading Clinical stage stem cell organisation with a fantastic reputation and friendly team.
The Company have to a new, custom-built facility that houses the R&D Group, CMC Group and a new state of the art manufacturing facility based in the South Wales. Once the manufacturing site is fully operational, it will support both clinical and commercial drug product supply.
CMC Project Manager will be a key member of the team responsible for developing the manufacturing processes, their establishment at CMOs, the clinical supply chain and generation of submission ready reports.
The CMC Project Manager will be a key member of the CMC team with responsibilities including:
*Developing the CMC plans detailing technology transfer and the delivery of development data to support an IND/IMPD or CTD for licensure.
*Building an effective and collegiate relationship with pivotal CMOs to ensure processes are transferred and are operational to support clinical and commercial production
*Develop and track project specific CMC budgets and establish effective project change control governance for when changes are required
*Degree or equivalent, in a biological science or related technological field
*Strong background in project management
*An understanding of the drug development process, CMC and biologics would be a particular advantage
*Ability to establish processes which lead to effective project progression and visibility
*Experience with documentation and practices in a regulated environment preferred (e.g. GMP, GLP)
*Strong desire to take ownership of projects and drive their delivery
*The position may require up to 20% travel
Get in touch with Fareen Choudhry for more information: / 01737 236 737
CMC / Chemistry, Manufacturing and Controls / GMP / GLP/ Pharmaceutical / Project Management / PM / Biologics / Stem Cell / Cell Therapy / Clinical / Technical manager / Development / South Wales /CTD / CMO / IND / IMPD / Technology / Manufacturing / Drug development / R&D / Research & Development / Investigational New Drug / Investigational Medicinal Product Dossier / Contract Manufacturing Organisation
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