Process Development Scientist - Formulation & Aseptic Fill

QRC Group, LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

QRC Group, LLC in Juncos, Puerto Rico is seeking a Process Development Scientist to provide technical support for commercial bio pharmaceutical manufacturing, with a focus on formulation and aseptic filling processes. You will monitor processes, troubleshoot issues, and drive continuous improvements while ensuring quality and regulatory compliance.

The role requires collaboration with cross-functional teams, supporting investigations, deviations, and product impact assessments, and on-the-floor

Qualifications

• PhD or MSc/BSc with relevant experience required.
• Experience in commercial biotech manufacturing, preferably formulation and aseptic filling.
• Understanding of protein science, formulation processes and aseptic filling operations.
• Experience with process monitoring, data analysis, trending and JMP or similar tools.
• Experience supporting deviations, investigations, root cause analysis and product impact assessments.
• Provide direct manufacturing floor support in GMP environment.
• Strong technical writing for regulatory inspections and audits.

Responsibilities

• Provide technical support for formulation and aseptic filling operations.
• Monitor processes, troubleshoot manufacturing issues and drive continuous improvements.
• Support investigations, deviations and root cause analyses.
• Collaborate with cross-functional teams to ensure compliant manufacturing operations.

Skills

Process monitoring

Data analysis

Statistical software (JMP)

Root cause analysis

Cross-functional collaboration

Technical writing

Problem solving

Project management

Bilingual English/Spanish

Education

PhD in a scientific discipline

MSc in a scientific discipline + 2+ years

BSc in a scientific discipline + 4+ years

Tools

JMP

Job description

QRC Group, LLC in Juncos, Puerto Rico is seeking a Process Development Scientist to provide technical support for commercial bio pharmaceutical manufacturing, with a focus on formulation and aseptic filling processes. You will monitor processes, troubleshoot issues, and drive continuous improvements while ensuring quality and regulatory compliance.

The role requires collaboration with cross-functional teams, supporting investigations, deviations, and product impact assessments, and on-the-floor