Senior Aseptic Process Development 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

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