Descrizione:
Experteer Overview
In this MSAT Scientist role, you will lead technology transfer, scale-up, and optimization of bioprocesses within the MSAT team to enable scalable manufacturing. You will serve as a senior process expert, shaping the MSAT toolbox and acting as a long‑term process owner across development and commercial manufacturing. You’ll coordinate cross‑functional transfers, manage risk analyses, and ensure robust documentation and knowledge flow from development to production. This position offers meaningful impact in advancing RNA, nucleic acids, and biologics manufacturing at scale within a GMP‑driven environment.
Retribuzione / Benefits
- Lead technology transfer, design for scale‑up, and implement processes at manufacturing scale
- Coordinate multi‑functional teams and manage lifecycle of projects from planning to completion
- Perform GMP risk analyses and ensure process scalability and manufacturability
- Interface between process development/donor site and operations, ensuring effective information flow
- Drive Technology Transfer from Process Development, other sites, or Clients to Clinical/Commercial Manufacturing
- Prepare technical documents (Process GAP Assessments, TT Protocols, Sampling Plans, FMEA, Risk Assessments, VMP) for PPQ and commercialization
- Provide technical support for deviations, issue resolution, and continuous process improvement
- Develop and implement standardized MSAT procedures
- Supervise MSAT initiatives and lead troubleshooting teams
- Deliver process‑specific trainings for production staff
Responsabilità
- MS in life sciences, engineering, or equivalent technical field
- 2+ years in MSAT roles (preferred)
- strong manufacturing technical skills in nucleic acids, biologics, or vaccine production
- experience in Upstream (media prep, enzymatic reactions) and Downstream (TFF, chromatography, encapsulation, filtrations)
- cGMP knowledge and process engineering experience
- understanding of RNA production, analytics, scale‑up, process validation, and regulatory strategies
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