Principal Manufacturing Science and Technology (MSAT) Representative

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market. Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization.  Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, at Simtra, there is a strong emphasis on quality and continuous improvement.  We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging. In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies. It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.   The Principal Manufacturing Science and Technology (MSAT) Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS. This includes designing the manufacturing process(es) required for drug products. The Principal Technical Transfer Representative will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects. This position reports to the Sr. Manager, Technical Transfer.   What you'll be doing: Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies Serve as the lead technical expert among a cross functional team Lead the cross functional team through technical activities, development studies and PPQ batches Create technical transfer documents supporting this goal [Tech. Transfer Plan, process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), demonstration batch records, PPQ master batch record] Heavy participation / co-lead with Process Validation Representative on PPQ strategy and protocol development Lead during hand-off to the commercial team following PPQ batches Provides technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolves issues during manufacturing and leading process improvement activities Conduct Non-Conformance Report (NC...