Sr. Director, Manufacturing Sciences, Validation & Process Engineering Direct Hire MA

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Job ID: 15296 Direct Hire MA

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Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area.  This is with a mid-size company and they have a culture that can't be beat.  Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer.

The main function of this role is to lead several critical functions at the company as they prepare for commercialization.  These include Manufacturing Sciences, Validation, Emerging Technologies, CMC Project Management, and Process Engineering.  

Responsibilities include but are not limited to;
•  Build out technical functions to manage manufacturing process ownership of launched products, technology transfer, and manage the execution of process validation activities.
•  Drive the strategy for technical support and life-cycle management of our late-stage manufacturing processes
•  Facilitate/lead tech transfers for early and late stage clinical programs to/from CMOs or internal manufacturing.
•  Identify risks and drive continuous process improvement through technological innovation.
•  Lead an established team of high performers and grow the department to meet the needs of launching several commercial cell and gene therapy products.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher in Engineering or a relevant life science.  Advanced degrees welcome.  Must have demonstrated experience leading a diverse technical organization as well as external manufacturing providers and partners.  Cell therapy and/or gene therapy experience not required but welcome.  Must have experience successfully managing manufacturing sciences or process development functions in complex biological processes.  Preference given tothose with a track record of successfully supporting biologics programs through late-stage clinical development into commercialization.

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