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Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled 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, there is a strong emphasis on quality and continuous improvement at Simtra.  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.   Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.   Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.     This role: The MSAT Senior Associate is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at BPS. This includes designing the process(es) required for the new project. The MSAT Senior Associate 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 to Simtra. This position reports to the Sr. Manager, Technical Transfer.   The responsibilities: 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 clinical and/or 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, GMP clinical/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. The position is visible on the Manufacturing floor, resolves issues during manufacturing and leads process improvement activities. Conduct deviation (DEV) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA) Change Control Management (CCM) owner and impact assessment Ownership of fill volume dosing qualifications (FVOQ) Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements Grade A/B gowning qualification. Will enter Grade B areas for Batch support Participates in new project reviews to determine acceptable fit at Simtra