Drug/Device Formulation Development SME

Do you want to work with leaders in the rare-disease space as they bring therapeutics to market?  Do you have experience with the development of combination products, pre-filled syringes, or auto-injectors?  This is an amazing opportunity at a small, public company with an approved product on market and more coming soon!  Reporting into the Executive Director, this role will be part of the Technical Operations team.    

The main function of this role is to lead the combination product development process including characterization testing, design verification, manufacturing process definition and support of device development.  

Responsibilities include but are not limited to;
•  Develop and validate new methods and techniques for testing novel systems including design and validation
•  Lead technical interaction with drug product and device partners to develop, manufacture, and package products
•  Collaborate with partners in Supply Chain, QA, Regulatory Affairs, and various CRO/CMO’s 
•  Secure regulatory authority approvals/updates for any change controls
•  Support IND/IMPD/NDA/MAA filings and Design History Files for Combination products if required

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher in biomedical, mechanical or relevant engineering discipline preferred and 8-10+ years of experience in development of combination product, autoinjectors, pre-filled syringe or related products.  

Ideally looking for those commutable to the Boston area on a hybrid weekly schedule or able to relocate with limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.