R&D / Mfg Scientist III (MSAT Tech Transfer)
About the Role
Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scale‑up. Support client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provide scientific justification as needed and update status of project work. Technically supports day‑to‑day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. Leads technical/scientific process/product/project activities to implement strategies and technical solutions. Drives creation of processes, single‑use systems, and equipment designs for clinical, scale‑up, and/or registration batches, including technology transfer of projects from clients. Makes decisions that involve direct application of technical knowledge.
Responsibilities
- Design, implement, and evaluate studies; lead tech transfer, commercial scale‑up and support process validation.
- Represent the organization on formal technical and scientific forums.
- Lead and/or participate in problem solving and project work for formulations, equipment and processes.
- Write/revise work orders for new processes, FORMs, reports, memos, and protocols as required.
- Independently manage projects, proficient in evaluating and organizing all technical aspects of the project to achieve necessary landmarks and turning points.
- Support manufacturing operations, change controls, investigations as subject matter expert (SME); resolve accurate CAPAs.
- Assess material changes and determine change impact