Process Development Senior Scientist

QRC Group, LLC; Juncos (PR); On-site; USD 110,000 - 160,000; Full time

Job summary

QRC Group, LLC is seeking a Senior Process Development Scientist to support sterile drug product manufacturing. You will lead aseptic processing efforts, data-driven process characterization, and tech transfer across cross-functional teams in a fast-paced environment.

The role requires expertise in PPQ, GMP, and quality systems, with strong scientific writing and project management skills to enable manufacturing readiness and continuous improvement in Puerto Rico.

Qualifications

• Degree in engineering or related scientific discipline is highly preferred.
• Experience with sterile drug product manufacturing.
• Experience with aseptic filling operations, process validation (PPQ), and tech transfer.
• Strong GMP knowledge, aseptic processing principles, and contamination control.

Responsibilities

• Provide scientific leadership to support manufacturing readiness and continuous process improvement.
• Support sterile drug product manufacturing and data-driven process optimization.
• Author/execute validation protocols, characterization studies, technical reports, investigations, and change controls.
• Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, Regulatory, and Technical Services.

Skills

Aseptic processing

Process characterization

Process validation

Technology transfer

Data analysis

GMP knowledge

Statistical analysis

Cross-functional teamwork

Technical writing

Project management

Single-use tech

Education

Bachelor's degree

Master's degree

PhD/ Doctorate

Tools

JMP

Minitab

LIMS

HLEE

Job description

Juncos, Puerto Rico

We are seeking a Senior Process Development Scientistto 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