Process Development Senior Scientist

QRC Group; Juncos (PR); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

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

Educación

Bachelor's degree in STEM

Master's degree (or higher)

PhD/PharmD/MD with relevant postdoc experience

Herramientas

JMP

Minitab

LIMS

HLEE

Descripción del empleo

Juncos, Puerto Rico | Posted on 09/10/2026

We are seeking a Senior Process Development Scientist to support sterile drug product manufacturing operations within the pharmaceutical or biotechnology industry. The ideal candidate will have strong expertise in aseptic processing, process characterization, process validation, technology transfer, data analysis, and commercial process support. This role requires the ability to work cross-functionally while providing scientific and technical leadership to support manufacturing readiness and continuous process improvement.

Requirements

• A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred. Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or Master's degree with 3+ years of relevant scientific experience; or Bachelor's degree with 5+ years of relevant scientific experience.
  
• Experience with statistical software (JMP or Minitab) and Sample Management System such as LIMS and HLEE.
  
• Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
  
• Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
  
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
  
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
  
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
  
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
  
• Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
  
• Strong technical writing, communication, presentation, and project management skills.
  
• Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
  
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable