Director, Global Apheresis Operations (Cell & Gene Therapy) Direct Hire MA

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Job ID: 16313 Direct Hire MA

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Build and lead a world class Apheresis Operations function that is focused on delivering an excellent patient and stakeholder experience as it relates to the collection of patient cells.  Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area.  This role 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 as they prepare for commercial launch.

The Hiring Manager is seeking the following skills and experience. Do you match one of these profiles?  

Profile I: Extensive Business Operations experience, ideally in a hospital setting.  Experience with blood collection, community based blood centers.  The Business Operations experience can be either on collection side or the hospital/institution side, working closely with blood collection activities.  Do you have experience scaling an Operation, specifically going from clinical to commercial?  

Profile II: Phenotype of CMC expert who has worked in industry and worked closely with Clinical Operations and is familiar with the considerations in a hospital setting.  Experience going from clinical to commercial and familiar with the Drug Development process and commercial considerations of launching a product.  Are you Directing a Patient Services group of Nurse Navigators/Nurse Educators and interact directly with patients?  

The main function of this role is to implement the systems, processes, framework, and infrastructure for future scale of Global Apheresis Operations.  You will lead the development of the function during the transition to launching the company's first commercial product!

Responsibilities include but are not limited to;

• Manage the business operations and network aspects of working with hospitals & treatment centers to ensure successful collection of patient cells. This includes; developing a metrics program for assessing key performance indicators as it relates to managing a cell procurement network of collection sites, collaborate with Commercial Operations and QA to ensure that the cell procurement centers are compliant with all necessary regulations, and engage in the implementation of best practices between cell collection sites. 

• Develop a training program for the cell procurement process and manage a team of field apheresis nurses in the US and Europe.
• Build systems and teams that will drive data collection and analysis in support of optimizing collection procedures, efficiency, and quality.

• Ensure the traceability of patient collected cells through the patient treatment pathway by working closely with Global supply Chain Department.

• Drive continuous improvement in the cell collection process through technological innovation.

• Develop strategic plans for scaling the network of Qualified Treatment Centers both domestically and globally.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher (RN or advanced degree preferred but not required) and 10-15+ years of industry experience in either industry or hospital-based apheresis operations and/or cell therapy operations.  Must also have a good understanding of applicable regulations and standards (GMPs, GCPs, AABB, FACT JACIE). 

Must be authorized to work in the US indefinitely to be considered.  Relocation assistance available for qualified candidates.  

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