About The Position

Serve as the technical owner for spray-dry, solid-dose, and packaging processes conducted at external manufacturing partners (CMOs) for a global pharmaceutical company in Carolina, Puerto Rico. The role focuses on troubleshooting and investigating process issues, leading technology transfers, and maintaining validated processes in a state of control. This is a six-month contract with possible extension, Monday–Friday core hours, and 24/7 support as needed across time zones. The stated start is immediate.

Requirements

  • Bachelor's degree in Chemistry, Pharmacy, or Engineering.
  • At least 5 years of hands-on experience with spray-dry dispersion, solid-dose manufacturing, and packaging.
  • Experience supporting CMOs or external manufacturing and technology transfer.
  • Experience supporting GMP inspections in FDA-regulated manufacturing.
  • Experience with TrackWise, SAP, and statistical analysis.
  • Fluency in English and Spanish.

Responsibilities

  • Provide technical oversight of spray-dry, oral solid-dose (OSD), and packaging processes at CMOs.
  • Author deviations and change controls.
  • Lead root-cause investigations and drive on-time CAPA closure.
  • Support technology transfer, process qualification, and validation campaigns.
  • Monitor process capability using statistical methods.
  • Support GMP inspections.
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