Process Development Senior Scientist - Sterile Drug Product

BioPharma Consulting JAD Group

2d

About The Position

Join the process development team supporting commercial sterile vial filling at a biotechnology company in Juncos, Puerto Rico. This hands-on development role focuses on designing studies and establishing process parameters to maintain robust aseptic manufacturing. The position involves process characterization and optimization, troubleshooting commercial process issues, data analysis, technical writing, and support for PPQ and technology transfer.

Requirements

• Bachelor's degree and 5 years of experience, Master's degree and 3 years of experience, or a PhD/PharmD in Engineering, Pharmaceutical Sciences, Biotechnology, Biology, or Microbiology.
• Experience developing processes and establishing parameters for sterile drug product; experience limited to validation is not sufficient.
• Experience with aseptic processing, contamination control, and GMP.
• Experience with JMP or Minitab and LIMS.
• Bilingual in English and Spanish.

Responsibilities

• Design and run process characterization and optimization studies for aseptic filling.
• Set and justify process parameters.
• Troubleshoot commercial process issues.
• Analyze data in JMP or Minitab and recommend improvements.
• Author protocols, technical reports, investigations, and change controls.
• Support PPQ and technology transfer.

What This Job Offers

• Career Level: Senior