Process Development Senior Scientist - Sterile Drug Product

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 90,000 - 120,000; Part time

Job summary

Biopharma-Consulting-Jad-Group seeks a hands-on process development specialist in Juncos, Puerto Rico, to design characterization and optimization studies for aseptic filling and to set robust process parameters. This is a development role focused on improving commercial sterile drug production, not just documentation.

The role requires expertise in aseptic processing, GMP and data analysis using JMP or Minitab.

Qualifications

• Bachelor's degree + 5 years, Master's + 3 years, or PhD/PharmD in Engineering, Pharmaceutical Sciences, Biotechnology, Biology or Microbiology.
• Experience developing processes and establishing parameters for sterile drug product (not only validation).
• Aseptic processing, contamination control and GMP.
• JMP or Minitab, LIMS; bilingual English/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 tech transfer.

Skills

Process development

Aseptic filling

Data analysis

Education

Bachelor/Master/PhD or PharmD in Engineering/Pharmaceutical Sciences/Biology/Biotechnology/M Microbiology

Tools

JMP

Minitab

LIMS

Job description

Join the process development team that supports commercial sterile vial filling at a leading biotechnology company in Juncos, Puerto Rico. You will design the studies and set the process parameters that keep aseptic manufacturing robust. This is a hands-on development role, not a documentation role.

What you'll do

• 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 tech transfer.

• Bachelor's degree + 5 years, Master's + 3 years, or PhD/PharmD (Engineering, Pharmaceutical Sciences, Biotechnology, Biology or Microbiology).
• Experience developing processes and establishing parameters for sterile drug product (not only validation).
• Aseptic processing, contamination control and GMP.
• JMP or Minitab, LIMS; bilingual English/Spanish.

• Contract: 6 months, with possible extension
• Shift: Administrative, Monday-Friday
• Start: Immediate