Packaging Engineering, Cell & Gene Therapy Direct Hire MA

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Job ID: 16315 Direct Hire MA

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Are you an expert in Packaging Engineering for biotech, pharmaceutical, gene therapy or medical device products?  Do you have experience with shipping qualifications, defining suitable label stocks, defining specifications for labels, etc.?  If so, this is an opportunity you can't pass up!   

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. 

The main function of this role is to lead efforts to align and optimize primary and secondary packaging solutions based on operational requirements for cell & gene therapy products and define and implement robust processes and procedures for developing and managing labeling processes.

Responsibilities include but are not limited to;
•  Lead the design, development, implementation, and maintenance of primary, secondary and tertiary packaging for viral and cell therapy products and intermediates
•  Manage relationship with Cold Chain and Packaging vendors and provide oversight of packaging and labeling activities at internal and external manufacturers/CMOs
•  Lead qualification activities for all shipping systems for Cold Chain materials
•  Development of packaging User Requirement Specification (URS) documents 
•  Integrate regulatory, technical, and branding requirements into the design of compliant Cell Collection, Drug Product labels used for domestic and international clinical trials and commercial markets
•  Support product traceability system at clinical and commercial collection centers and external manufacturers
•  Lead change management processes for labeling, including the development or revision of Label Specifications & Label Proofs
•  Support activities related to selection and implementation of labeling stock at CMO’s 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher in in Engineering or Packaging Science and 5-10+ years of experience in a GMP environment.  Title will be commensurate with experience and the Hiring Manager is open to individual contributors and those with previous management experience.  Excellent interpersonal, verbal and written communication skills are required for this role.  Qualified candidates must be able to demonstrate a history of working cross-functionally with internal groups (Regulatory Affairs, Artwork, etc.) and with external vendors, partners or CMOs.     

Must be authorized to work in the US indefinitely to be considered. This role is based in Cambridge.  Unfortunately, remote-based employees can not be considered at this time.  Relocation assistance may be available for qualified candidates.   

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