Process Development Scientist: Formulation & Filling

QRC; Juncos (PR); On-site; USD 110,000 - 140,000; Full time

Job summary

QRC Group, LLC is seeking a Process Development Scientist to provide technical support for commercial biopharmaceutical manufacturing, with a focus on formulation and aseptic filling. This role covers process monitoring, troubleshooting, investigations, and driving continuous improvements while ensuring quality and regulatory compliance.

The role requires collaboration with cross-functional teams, knowledge of protein science, and the ability to prepare regulatory documentation.

Qualifications

• PhD in a scientific field or MS with 2+ years of relevant experience; or BA/BS with 4+ years in a scientific field.
• Experience in a commercial biotech manufacturing environment, esp. 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 software.
• Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
• Experience providing manufacturing floor support in GMP environment.
• Strong technical writing for regulatory documentation.
• Excellent communication, presentation, problem-solving, and project management skills.
• Ability to collaborate with cross-functional teams.
• Bilingual English and Spanish (written and verbal).

Responsibilities

• Provide technical support for formulation and aseptic filling operations.
• Monitor processes and troubleshoot manufacturing issues.
• Support deviations, investigations, root cause analyses, and product impact assessments.
• Collaborate with cross-functional teams to ensure regulatory compliance.
• Prepare documentation for regulatory inspections and audits.

Skills

Technical writing

Communication

Project management

Cross-functional collaboration

Bilingual English/Spanish

Education

Doctorate

Master's degree with 2+ years

Bachelor's degree with 4+ years

Tools

JMP

Job description

QRC Group, LLC is seeking a Process Development Scientist to provide technical support for commercial biopharmaceutical manufacturing, with a focus on formulation and aseptic filling. This role covers process monitoring, troubleshooting, investigations, and driving continuous improvements while ensuring quality and regulatory compliance.

The role requires collaboration with cross-functional teams, knowledge of protein science, and the ability to prepare regulatory documentation.