Senior Aseptic Process Development Scientist

QRC

Juncos (PR)

On-site

USD 120,000 - 180,000

Full time

4 days ago

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Job summary

QRC Group, LLC is seeking a Senior Process Development Scientist to support sterile drug product manufacturing operations in the pharmaceutical or biotechnology sector. You will provide scientific and technical leadership to enable manufacturing readiness and continuous process improvement.

The ideal candidate has strong expertise in aseptic processing, process characterization, validation (PPQ), technology transfer, data analysis, and cross-functional collaboration with Manufacturing, Quality,

Qualifications

Degree in engineering or life sciences; advanced degrees preferred.
Experience with aseptic filling, process characterization, validation, tech transfer.
Experience with GMP, contamination control, pharmaceutical quality systems.
Strong statistical analysis using JMP or Minitab.
Ability to analyze manufacturing data and drive improvements.
Experience working cross-functionally with Manufacturing, Quality, Regulatory.
Excellent technical writing, communication and project management.
Fully bilingual in English and Spanish.

Responsibilities

Support sterile drug product manufacturing operations.
Provide scientific and technical leadership for manufacturing readiness and continuous process improvement.
Lead process characterization, validation (PPQ) and technology transfer.
Analyze data to identify trends and drive improvements.
Collaborate across Manufacturing, Quality, Engineering, Regulatory and Technical Services.
Author and execute validation protocols and technical reports.
Manage multiple projects in a fast-paced environment.
Experience with single-use technologies and sterile manufacturing is desirable.
Fully bilingual in English and Spanish.