Process Development Scientist

Hace 1 semana

Juncos, Puerto Rico Qrc Group Llc Jornada completa

We are seeking a Senior Process Development Scientist to support sterile drug product manufacturing operations within the pharmaceutical or biotechnology industry. The ideal candidate will have strong expertise in aseptic processing, process characterization, process validation, technology transfer, data analysis, and commercial process support. This role requires the ability to work cross-functionally while providing scientific and technical leadership to support manufacturing readiness and continuous process improvement.

Requisitos:

A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred. Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or Master's degree with 3+ years of relevant scientific experience; or Bachelor's degree with 5+ years of relevant scientific experience. Experience with statistical software (JMP or Minitab) and Sample Management System such as LIMS and HLEE. Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry. Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support. Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls. Strong knowledge of GMP requirem