Senior Process Development Scientist - Sterile Pharma

Frey Consulting Group; Juncos (PR); Hybrid; USD 95,000 - 135,000; Part time

Job summary

Frey Consulting Group seeks an experienced Senior Process Development Scientist to independently design and lead experiments advancing biopharmaceutical processes. You will interpret complex data, guide technical decisions, and drive process development within a regulated environment.

The role requires cross-functional leadership, strong writing and communication skills, and experience with sterile manufacturing, validation, and technology transfer. Hybrid onsite support is offered.

Qualifications

• Experience supporting sterile drug product manufacturing.
• 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 strategies, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.

Responsibilities

• Independently plan, monitor, and conduct experiments to advance projects, technologies, and processes.
• Provide advanced data analysis, interpret results, and make scientifically grounded recommendations.
• Develop new experimental designs, protocols, methodologies, and approaches.
• Lead cross-functional collaboration to support process development and manufacturing initiatives.

Skills

Sterile drug product manufacturing

Aseptic processing

Data analysis

Technical writing

Project management

Cross-functional collaboration

Bioprocess engineering knowledge

Bilingual English/Spanish

Chemical engineering knowledge

Education

Doctorate (PhD, PharmD, or MD)

Master’s degree

Bachelor’s degree

Tools

JMP

Minitab

LIMS

HLEE

Microsoft Office

Job description

Frey Consulting Group seeks an experienced Senior Process Development Scientist to independently design and lead experiments advancing biopharmaceutical processes. You will interpret complex data, guide technical decisions, and drive process development within a regulated environment.

The role requires cross-functional leadership, strong writing and communication skills, and experience with sterile manufacturing, validation, and technology transfer. Hybrid onsite support is offered.