Senior Sterile Process Development Scientist

QRC Group, LLC; Juncos (PR); On-site; USD 110,000 - 160,000; Full time

Job summary

Senior Process Development Scientist in Juncos, Puerto Rico, leads aseptic process development for sterile drug products and ensures readiness for manufacturing scale-up and commercialization.

The role requires deep expertise in process characterization, validation, technology transfer, and data-driven optimization, with strong GMP and quality systems knowledge. Cross-functional collaboration is essential to drive improvements and compliance.

Qualifications

• Advanced degree in engineering, biotechnology, pharmaceutical sciences, or related field with substantial post-degree experience.
• Experience with aseptic filling operations and sterile manufacturing environments.
• Strong GMP knowledge and familiarity with quality systems and contamination control.
• Experience planning, executing, and documenting validation and characterization studies.
• Proven ability to analyze manufacturing data and drive data-driven improvements.
• Experience authoring technical reports, investigations, and change controls.
• Cross-functional collaboration across Manufacturing, Quality, Engineering, and Regulatory teams.

Responsibilities

• Lead aseptic process development activities for sterile drug products.
• Drive process characterization, validation (PPQ), and tech transfer to manufacturing.
• Support readiness for manufacturing scale-up and commercial deployment.
• Apply statistical methods to analyze data and optimize processes.
• Prepare technical reports, investigations, and change controls.
• Collaborate with cross-functional teams to ensure quality and compliance.

Skills

Aseptic processing

Process characterization

Process validation

Technology transfer

Data analysis

GMP knowledge

Statistical analysis

Technical writing

Project management

Cross-functional collaboration

Education

Doctorate (PhD/PharmD/MD)

Master's degree

Bachelor's degree

Tools

JMP

Minitab

LIMS

HLEE

Job description

Senior Process Development Scientist in Juncos, Puerto Rico, leads aseptic process development for sterile drug products and ensures readiness for manufacturing scale-up and commercialization.

The role requires deep expertise in process characterization, validation, technology transfer, and data-driven optimization, with strong GMP and quality systems knowledge. Cross-functional collaboration is essential to drive improvements and compliance.