Simtra BioPharma Solutions

D365 System Site Owner, Pharmaceutical Manufacturing

Bloomington, Indiana, United StatesFull timePosted 1 day ago
Apply on Simtra BioPharma Solutions →

Sign into see who you know at Simtra BioPharma Solutions.

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 Dynamics 365 (D365) System Owner provides strategic leadership and business ownership of the Microsoft Dynamics 365 platform within a pharmaceutical contract manufacturing (CDMO/CMO) environment. This role is responsible for driving the governance, optimization, and continuous improvement of D365 to support Supply Chain, Manufacturing, Inventory Management, Procurement, Planning, Warehousing, and related business operations. Partnering closely with cross-functional teams including Supply Chain, Manufacturing, Quality, Finance, Regulatory Affairs, Validation, and IT, the D365 System Owner ensures system capabilities align with business objectives, GMP and regulatory requirements, and organizational growth strategies while enhancing operational efficiency, data integrity, and overall business performance.   The responsibilities: Serve as the business owner and subject matter expert for Microsoft Dynamics 365 Supply Chain Management, ensuring alignment with business objectives and operational needs. Establish and maintain ERP governance, business processes, system standards, and user adoption strategies. Lead system roadmap planning, enhancement prioritization, and cross-fu...