Senior Aseptic Process Development Scientist

QRC; Juncos (PR); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

QRC Group, LLC is seeking a Senior Process Development Scientist to support sterile drug product manufacturing within pharma/biotech. The role emphasizes aseptic processing, process characterization, validation, technology transfer, data analysis, and cross-functional leadership to ensure manufacturing readiness and continuous improvement.

The candidate will demonstrate strong scientific writing, project management, and collaboration with Manufacturing, Quality, and Regulatory teams to deliver

Formación

• Advanced degree with relevant postdoctoral experience or work history.
• Experience supporting sterile drug product manufacturing in pharma/biotech.
• Hands-on experience with aseptic filling, PPQ, tech transfer, and process support.
• Proven ability to author/execute validation protocols and reports.
• Strong GMP knowledge and contamination control understandings.

Responsabilidades

• Provide scientific/technical leadership for manufacturing readiness and continuous process improvement.
• Work cross-functionally with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Develop and validate manufacturing processes and transfer to production.
• Analyze manufacturing data, identify trends, and recommend solutions.

Conocimientos

Aseptic processing

Process characterization

Process validation

Technology transfer

Data analysis

Statistical software (JMP/Minitab)

GMP knowledge

Cross-functional collaboration

Scientific writing

Project management

Educación

PhD in relevant field

MS with 3+ years experience

BS with 5+ years experience

Herramientas

LIMS

HLEE

JMP

Minitab

Descripción del empleo

QRC Group, LLC is seeking a Senior Process Development Scientist to support sterile drug product manufacturing within pharma/biotech. The role emphasizes aseptic processing, process characterization, validation, technology transfer, data analysis, and cross-functional leadership to ensure manufacturing readiness and continuous improvement.

The candidate will demonstrate strong scientific writing, project management, and collaboration with Manufacturing, Quality, and Regulatory teams to deliver