Senior Process Development Scientist, Aseptic Manufacturing

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

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.