Process Development Scientist – Biopharma (Hybrid, 24/7 Support)

ProQualityNetwork; Juncos (PR); Hybrid; USD 90,000 - 130,000; Full time

Job summary

ProQualityNetwork in Puerto Rico seeks a Process Development Scientist to design, execute, and evaluate experiments that advance manufacturing processes. You will generate reliable data and contribute to process development objectives in a fast-paced, 24/7 environment.

The role requires strong scientific writing, proficiency in English and Spanish, and collaboration across functions to drive improvements and regulatory readiness. Hybrid onsite preference in Juncos, PR.

Qualifications

• MS or BS with relevant scientific experience in process development.
• Experience in commercial biopharmaceutical manufacturing, preferably formulation and aseptic filling.
• Knowledge of protein science, formulation, and filling processes.
• Experience with process monitoring, data trending, and statistical tools such as JMP.
• Experience with deviations, investigations, and root cause analysis.
• Ability to provide manufacturing floor support in a fast-paced 24/7 environment.
• Bilingual fluency in Spanish and English.
• Strong technical writing for regulatory audits.

Responsibilities

• Conceive, design, execute, and evaluate scientific experiments and strategies.
• Develop and assess experimental approaches for new processes and reliable data.
• Ensure studies follow approved protocols and regulatory requirements.
• Analyze data and interpret results to assess impact on objectives.
• Stay current with scientific developments and industry literature.
• Provide technical guidance on experimental design and troubleshooting.
• Prepare scientific reports, technical summaries, and regulatory documentation.
• Support department initiatives, including safety programs and recruiting.
• Establish and manage project timelines to deliverables.

Skills

Biopharmaceutical manufacturing

Process development

Data analysis

Regulatory understanding

Cross-functional collaboration

Bilingual Spanish/English

Education

MS in Science/Engineering

BS in Science/Engineering

Tools

JMP

Job description

ProQualityNetwork in Puerto Rico seeks a Process Development Scientist to design, execute, and evaluate experiments that advance manufacturing processes. You will generate reliable data and contribute to process development objectives in a fast-paced, 24/7 environment.

The role requires strong scientific writing, proficiency in English and Spanish, and collaboration across functions to drive improvements and regulatory readiness. Hybrid onsite preference in Juncos, PR.