Manufacturing Technical Services Representative

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 Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services. The responsibilities: Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs Review and release commercial batch records to production for execution Train manufacturing personnel on new and/or significant changes to MBRs Investigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s) Authors technical studies in support of investigations or process improvements Own change controls and associated tasks Approve project related Bill of Materials Commercial contact for assigned internal and external clients Manages client project updates and reviews with all levels of management Participate (with assistance) in Business Review Meetings Partner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information Participate on client calls and on-site visits to discuss projects and issue resolutions Participate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations Evaluates non-conformance situations for product impact and responsible for advising if product meets release criteria Use knowledge of manufacturing systems and equipment to write batch record and perform other duties Understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product Required qualifications: BS degree, preferably in a science-related field Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality S…