Lead Scientist, Aseptic Filling & Process Validation

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 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.