Senior Process Development Scientist — Aseptic Sterile Fill

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 55,000 - 83,000; Full time

Benefits offered by this job

6-month contract

Mon-Fri schedule

Immediate start

Job summary

BioPharma Consulting JAD Group is seeking a hands-on process development professional for aseptic vial filling in Juncos, Puerto Rico. You will design studies, set parameters, and ensure robust aseptic manufacturing, with a focus beyond documentation.

The role involves creating characterization and optimization studies, parameter justification, and data-driven improvements. Candidates should have strong GMP knowledge and be fluent in English and Spanish.

Qualifications

• Bachelor's degree with 5+ years experience or advanced degree (Master’s/PhD/PharmD) in Engineering, Pharmaceutical Sciences, Biotechnology, Biology or Microbiology.
• Experience developing processes and establishing parameters for sterile drug products, not limited to validation.
• Aseptic processing, contamination control and GMP knowledge.
• Proficiency with JMP or Minitab; 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

Aseptic processing

GMP

Contamination control

Education

Bachelor's degree + 5 years / Master’s + 3 years / PhD or PharmD

Tools

JMP

Minitab

LIMS

Job description

BioPharma Consulting JAD Group is seeking a hands-on process development professional for aseptic vial filling in Juncos, Puerto Rico. You will design studies, set parameters, and ensure robust aseptic manufacturing, with a focus beyond documentation.

The role involves creating characterization and optimization studies, parameter justification, and data-driven improvements. Candidates should have strong GMP knowledge and be fluent in English and Spanish.