Process Development Senior 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

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