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