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R&D Technical Services Scientist I (New Albany, OH)

Cedent

R&D Technical Services Scientist I (New Albany, OH) Responsible for Technology Transfer and process scale up activities associated with parenteral drug products. Supports cross‑functional Production, Engineering, Quality Assurance, and Validation departments to troubleshoot manufacturing issues. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Essential Duties And Responsibilities Design and execute experiments for tech transfer, process R&D/scale‑up/validation, and other activities needed to introduce new or existing products into a cGMP manufacturing site. Work with Production, Engineering, QA, and Validation departments for equipment qualification, process scale‑up, optimization, and validation. Coordinate with CMOs for external technology transfers (if required). Work with R&D project leads and develop robust technology transfer processes from lab scale to manufacturing site. Design, coordinate, and execute laboratory experiments to study material compatibility. Draft engineering protocols, technology transfer reports, and master batch records. Generate documents in support of regulatory submissions. Ensure all work is performed and documented in accordance with company policies, procedures, cGMP, and health and safety requirements. Perform any other tasks/duties as assigned by management. Education Requirements And Qualifications Bachelor’s degree with 4‑6 years progressive experience in technical services encompassing tech transfer, troubleshooting, and process optimization (required). Master’s degree in chemical engineering or pharmaceutical chemistry with 2‑3 years experience (preferred). Broad knowledge of process development and scale‑up of sterile injectable products (essential). “Outside‑the‑box” thinking and collaborative mindset (required). Hands‑on skills with laboratory instruments such as particle sizer, HPLC, Karl Fisher, DSC, etc. Knowledge of pharmaceutical lifecycle management (plus). Excellent organizational, interpersonal, and communication skills (required). Proficiency in Microsoft Office Word and Excel (required). Physical Environment And Requirements Physically able to wear laboratory protective gowning and equipment, including goggles, face shields, respirators, and protective gloves. Specific vision requirements: 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean‑shaven appearance each shift to wear tight‑fitting respirators properly. Position requires working in the laboratory as well as sitting. #J-18808-Ljbffr Cedent

Vacancy posted 2 days ago
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