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Senior Manager, Process Engineer / MSAT – T Cell

Posted 3 days ago

​My client, an extremely fast growing Allogeneic / T Cell company, received FDA approval for their leading compound and have entered into Phase 3 of their clinical trials. The momentum is high after generating significant series C funding, awards for their off-the-shelf VSTs technology, and now are hiring aggressively, with talent acquisition being a major company-wide initiative for the rest of 2021. Leadership is investing heavily in their CMC department, emphasis on their process development / MSAT capabilities as these functions will be instrumental at their phase of development. A newly created role has surfaced and they're in need of a talent Senior Manager, Process Engineer / MSAT – T Cell.

This position will be responsible for:

  • Represent Manufacturing Sciences and Technology on project core teams as a Subject Matter Expert (SME) to coordinate multi-functional activities for clinical and commercial cell therapy manufacturing processes

  • Lead technology transfer activities, address issue resolution, meeting quality system requirements, etc.

  • Maintain process history database and perform data analysis

  • Apply novel technological approaches for operational improvements

  • Support quality investigation and data analysis as SME to address deviation and implement change controls.

  • Identification and implementation of vial adapter for use with the commercial Drug Product

  • Optimizes processes to support clinical manufacturing, scale up, technology transfer, validation, and regulatory filings.

Qualifications / experiences:

  • Bachelor or Master’s Degree (preferably) in in engineering, chemistry, or a related scientific discipline

  • Minimum 5 years of experience MS&T, process validation, Tech Transfer, of upstream development in cell line or cell culture

  • Evidence of overseeing Proteins / Large Molecules, ideally T Cell, CART/ AAV / Gene Tx

  • Proficient in Technical writing / documenting