Process Development Senior Scientist

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

Job summary

QRC Group, Inc. seeks a Senior Process Development Scientist to advance sterile drug product manufacturing through aseptic processing, characterization, validation, and tech transfer.

This role guides cross-functional teams to ensure manufacturing readiness and ongoing process improvement. The candidate will analyze manufacturing data, develop scientifically sound solutions, and author technical reports while collaborating with Quality, Regulatory, and Engineering to enable compliant commercial

Qualifications

• PhD/MD/PharmD with postdoc or MS with 3+ years of relevant experience.
• Experience with JMP or Minitab statistical software.
• Experience supporting sterile drug product manufacturing.
• Hands-on experience with aseptic filling, characterization, validation, tech transfer, and commercial support.
• Strong GMP knowledge and pharmaceutical quality systems.
• Experience performing statistical analysis and data-driven process optimization.

Responsibilities

• Provide scientific and technical leadership to support manufacturing readiness and continuous improvement.
• Lead aseptic filling operations and participate in process validation (PPQ).
• Drive technology transfer and support commercial processes.
• Analyze manufacturing data to identify trends and optimize processes.
• Collaborate with Manufacturing, Quality, Engineering, Regulatory and Technical Services.

Skills

Aseptic processing

Process characterization

Process validation

Technology transfer

Data analysis

Statistical software

Education

Bachelor's degree in Engineering or related science

Master's degree

PhD/PharmD/MD with relevant postdoctoral experience

Tools

LIMS

HLEE

Job description

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.