Dry External Manufacturing Scientist — Tech Transfer & 24/7 Ops

Biopharma-Consulting-Jad-Group

Carolina (PR)

Sur place

USD 83 000 - 138 000

Plein temps

Il y a 5 jours
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Résumé du poste

Biopharma-Consulting-Jad-Group seeks a TS/MS Scientist – Dry External Manufacturing to provide technical oversight for spray drying, solid dosage manufacturing and packaging at external partners. Strong background in cGMPs and regulatory guidance is required, with 5+ years of hands-on experience and excellent written communication.

The role supports process validation, CAPA, technology transfer, and cross-functional collaboration across sites, with flexibility for 24/7 operations and a 6-month

Qualifications

  • Bachelor’s degree in a scientific field required.
  • 5+ years hands-on spray dry and solid dosage exp.
  • Experience with cGMPs and global regulatory guidance.

Responsabilités

  • Provide technical oversight for spray dry, solid dosage manufacturing and packaging.
  • Investigate technical issues related to control strategy and manufacturing.
  • Author deviations and change controls with strong technical writing.
  • Lead root cause investigations supporting CAPA closure timelines.
  • Manage internal and external relationships with partners and teams.
  • Ensure processes are compliant, in control, and validated.
  • Document process validation state with data supporting capability.
  • Support external manufacturing partners and tech transfers.
  • Work across site functions to achieve technical objectives.
  • Support 24/7 operations across time zones as needed.

Connaissances

Spray dry
Solid dosage
Packaging processes
Regulatory knowledge
Cross-functional collaboration
Project management
Bilingual English/Spanish
Data management
Communication

Formation

Bachelor's degree in Chemistry, Pharmacy, or Engineering

Outils

TrackWise
SAP

Description du poste

Biopharma-Consulting-Jad-Group seeks a TS/MS Scientist – Dry External Manufacturing to provide technical oversight for spray drying, solid dosage manufacturing and packaging at external partners. Strong background in cGMPs and regulatory guidance is required, with 5+ years of hands-on experience and excellent written communication.

The role supports process validation, CAPA, technology transfer, and cross-functional collaboration across sites, with flexibility for 24/7 operations and a 6-month

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