Director of Manufacturing CMC - 2 Positions

 


CMC Directors


 


Our client, a growing biodefense firm based in Maryland is currently searching for qualified professionals to fill TWO Director of Manufacturing CMC roles created due to on-going product development and corporate growth.


 


Both positions will work as a member of multi-disciplinary teams, to ensure the development of novel, safe, and effective medicines in a timely and cost effective manner by handling several aspects of project management, technology assessment, and preparation of appropriate CMC sections for IND, NDA and BLA submissions, while ensuring that contracted staff meet compliance requirements.


 


CMC Director – Drug API and Formulation


 


This Director will provide hands-on direction for outsourcing all aspects of pharmaceutical formulation development, including:



formulation design


preparation of clinical supplies


packaging


scale-up


process validation.


 


CMC Director – Biologics Outsourcing


 


This Director will provide hands-on direction for outsourcing all aspects of the manufacturing of biologics including



vendor selection


contract negotiation


technology transfer


validation process troubleshooting


process troubleshooting. 


The individual will monitor performance on contracts and milestones to ensure successful delivery of products against time, quality and cost considerations.


 


To be considered for these position, the well qualified candidate will hold an advanced degree (MS/MA or PhD) in pharmacy, pharmaceutical sciences, chemical engineering, chemistry, or a related discipline, with at least 8 of experience in oral formulation development (OR an equivalent combination of education and experience), to include authoring of CMC sections of regulatory submissions and experience in all phases and all aspects of new product development, including preparation of clinical supplies.


 


As these positions will directly support Client’s efforts relating to national defense, US citizenship or US Permanent Residency status will be required.


 


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