Biopharma Process Development Scientist — Hybrid Contract

ProQuality Network; United States; Hybrid; USD 89,000 - 134,000; Full time

Job summary

ProQuality Network is seeking a Process Development Scientist to support formulation and aseptic filling operations within a fast-paced biopharmaceutical manufacturing environment. You will design, execute, and interpret experiments to drive process improvements and robust manufacturing processes.

The ideal candidate brings strong data analysis, troubleshooting, and cross-functional collaboration skills, with experience in cGMP environments and regulatory documentation.

Qualifications

• Experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
• Experience with process monitoring, data trending, and statistical analysis tools such as JMP or similar platforms.
• Experience supporting investigations, deviation management, root cause analysis, and product impact evaluations.
• Ability to provide hands-on manufacturing floor support within a dynamic 24/7 production environment.
• Strong technical writing skills with experience preparing documentation for regulatory inspections and audits.

Responsibilities

• Design, execute, evaluate, and interpret scientific experiments to support process development initiatives and project goals.
• Develop experimental strategies and provide technical recommendations to generate reliable and robust process data.
• Ensure studies are performed in compliance with approved protocols, cGMP requirements, and applicable regulatory guidelines.
• Analyze and interpret experimental data to assess project impact and support decision-making.
• Support process monitoring activities, data trending, and statistical evaluations to identify opportunities for improvement.
• Provide technical support for deviations, investigations, root cause analysis, and product impact assessments.
• Develop and implement new protocols, methodologies, and scientific approaches to address process challenges.
• Apply advanced scientific techniques and innovative solutions to improve process performance.
• Prepare technical reports, scientific summaries, regulatory documentation, and other required project deliverables.
• Maintain current knowledge of scientific advancements, industry trends, and emerging technologies relevant to process development.
• Collaborate with cross-functional teams, including manufacturing, quality, engineering, and technical operations.
• Participate in project teams and provide scientific expertise under general guidance from senior scientific staff.
• Support mentoring, knowledge-sharing, safety initiatives, and department-wide improvement activities as needed.
• Establish and manage project timelines to ensure successful completion of assigned activities.

Skills

Biopharma process development

Data analysis

Troubleshooting

Cross-functional collaboration

cGMP knowledge

Bilingual English/Spanish

Regulatory documentation writing

Project management

On-site manufacturing support

Process optimization

Education

Master’s degree

Bachelor’s degree

Tools

JMP

Job description

ProQuality Network is seeking a Process Development Scientist to support formulation and aseptic filling operations within a fast-paced biopharmaceutical manufacturing environment. You will design, execute, and interpret experiments to drive process improvements and robust manufacturing processes.

The ideal candidate brings strong data analysis, troubleshooting, and cross-functional collaboration skills, with experience in cGMP environments and regulatory documentation.