Senior Process Development Scientist

QRC; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

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.

Skills

Aseptic processing

Process characterization

Process validation

Technology transfer

Data analysis

GMP knowledge

Cross-functional collaboration

Technical writing

Project management

Bilingual English/Spanish

Single-use technologies

Filling operations

Education

Bachelor's degree + 5+ years

Master's degree + 3+ years

PhD/MD/PharmD + postdoc

Tools

LIMS

HLEE

Job description

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Job Description

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.

Qualifications

• 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
• Fully Bilingual (English and Spanish)

Additional Information

All your information will be kept confidential according to EEO guidelines.