Senior Sterile Process Development Scientist

QRC Group; Juncos (PR); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

QRC Group is seeking a Senior Process Development Scientist to support sterile drug product manufacturing in a fast-paced pharmaceutical/biotech setting. The role requires aseptic processing expertise, process characterization, validation (PPQ), and technology transfer, with data-driven optimization and cross-functional leadership to drive readiness and continuous improvement.

You will author protocols and reports, support cross-functional teams, and contribute to manufacturing efficiency and

Qualifikationen

• Degree in a scientific discipline is highly preferred.
• Experience with sterile drug product manufacturing.
• Hands-on aseptic filling operations and process validation.
• Experience authoring validation protocols and technical reports.
• Strong GMP knowledge and contamination control experience.
• Experience with data analysis and statistical tools.

Aufgaben

• Provide scientific and technical leadership for sterile manufacturing readiness and continuous process improvement.
• Lead cross-functional teams (Manufacturing, Quality, Engineering, Regulatory, Tech Services).
• Support technology transfer and commercial process support.
• Develop and execute validation and characterization studies; prepare technical reports and investigations.
• Analyze manufacturing data to identify trends and recommend improvements.

Kenntnisse

Aseptic processing

Process characterization

Process validation

Technology transfer

Data analysis

Cross-functional collaboration

Technical leadership

GMP knowledge

Statistical analysis (JMP/Minitab)

Data-driven optimization

Manufacturing data analysis

Technical writing

Project management

Single-use tech

Ausbildung

Bachelor's degree in STEM

Master's degree (or higher)

PhD/PharmD/MD with relevant postdoc experience

Tools

JMP

Minitab

LIMS

HLEE

Jobbeschreibung

QRC Group is seeking a Senior Process Development Scientist to support sterile drug product manufacturing in a fast-paced pharmaceutical/biotech setting. The role requires aseptic processing expertise, process characterization, validation (PPQ), and technology transfer, with data-driven optimization and cross-functional leadership to drive readiness and continuous improvement.

You will author protocols and reports, support cross-functional teams, and contribute to manufacturing efficiency and