Principal Scientist 35534

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 110,000 - 160,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico seeks a Principal Scientist to lead sterile drug product development and manufacturing support in a fast-paced environment.

The role emphasizes aseptic filling, process characterization and validation (PPQ), technology transfer, GMP compliance, and data-driven optimization, with cross-functional collaboration across Manufacturing, Quality, Engineering, Regulatory and Technical Services.

Qualifications

• Experience supporting sterile drug product manufacturing in pharma/biotech.
• Hands-on 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.

Responsibilities

• Lead sterile drug product manufacturing support in a fast-paced environment.
• Support aseptic filling operations, process characterization, and validation activities.
• Execute validation protocols, characterization studies, investigations, and change controls.
• Advise on GMP compliance, aseptic processing, and contamination control.
• Conduct statistical analysis to drive process optimization (JMP or Minitab).
• Analyze manufacturing data, identify trends, and propose scientifically sound solutions.
• Collaborate across Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Prepare technical documents and reports with strong writing and presentation.
• Manage multiple projects concurrently to enable commercial readiness and continuous improvement.
• Support single-use technologies and filling equipment initiatives.

Skills

Aseptic filling

Process validation

Technology transfer

Validation protocols

GMP

Aseptic processing

Contamination control

Quality systems

Statistical analysis

JMP

Minitab

Data analysis

Cross-functional teamwork

Technical writing

Project management

Single-use technologies

Filling equipment

Education

Doctorate (PhD, PharmD, or MD)

Masters degree with 3+ years experience

Bachelors degree with 5+ years experience

Engineering/Pharmaceutical sciences degree

Biomedical/Bioprocess engineering

Tools

LIMS

HLEE

Job description

Integrated Services For Productivity & Validation, Inc | Contract

Principal Scientist 35534

Juncos, Puerto Rico | Posted on 07/21/2026

Job Description

• 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.

Requirements

• 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.

A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred.

In addition to the minimum educational requirements listed below, candidates should have experience with technical data analysis and scientific documentation. Proficiency with Microsoft Office (Excel, Word, and PowerPoint) is required. Experience with statistical software (JMP or Minitab) and Sample Management System such as LIMS and HLEE.