Title: Process Development Scientist – Job Opportunity 35588

Hybrid Work Schedule | Non-Standard Shifts | Puerto Rico Residents Only

Contract Duration: 4 months

Work Schedule: 8:00 AM – 5:00 PM (Administrative Shift)



Schedule Flexibility:

Although the primary schedule is 8:00 AM – 5:00 PM, this position requires flexibility to support continuous formulation and filling operations. Based on business needs, extended hours, 12-hour shifts, nights, weekends, and holidays may be required.

Position Overview

Our client is seeking a Process Development Scientist to support formulation and aseptic filling operations within a commercial biopharmaceutical manufacturing environment. This role is responsible for designing, executing, and interpreting scientific experiments that support process improvements, project objectives, and the development of robust manufacturing processes.

The ideal candidate will have strong technical expertise in biopharmaceutical processes, data analysis, troubleshooting, and cross-functional collaboration, with the ability to provide scientific support in a fast-paced, 24/7 manufacturing environment.

Key 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.

Preferred Qualifications

• Experience working in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
• Strong understanding of protein science, formulation processes, and 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.
• Excellent communication, presentation, problem-solving, and project management skills.
• Ability to collaborate effectively with cross-functional teams.
• Fully bilingual in English and Spanish (written and verbal communication).

Education Requirements

Candidates must meet one of the following educational and experience combinations:

• Doctorate degree in a relevant scientific discipline.
• OR
• Master’s degree with at least 2 years of scientific experience.
• OR
• Bachelor’s degree with at least 4 years of scientific experience.

Required Skills and Competencies

• Advanced scientific analysis, troubleshooting, and problem-solving capabilities.
• Strong laboratory skills and ability to apply scientific principles to process challenges.
• Experience designing and executing scientific experiments and interpreting results.
• Strong understanding of cGMP requirements and regulated manufacturing environments.
• Ability to manage multiple projects, priorities, and changing business needs.
• Strong written and verbal communication skills, including technical documentation.
• Demonstrated negotiation, conflict resolution, and collaboration skills.
• Project management experience with the ability to meet established timelines.
• Ability to adapt to changing priorities and work effectively in a fast-paced environment.
• Computer proficiency within a Windows environment, including Microsoft Word, Excel, and PowerPoint.
• Creative and innovative approach to experimental design and scientific problem-solving.
• Ability to apply scientific theory and technical expertise to support manufacturing excellence.