Process Development Scientist – Hybrid | Puerto Rico

Position Summary

We are seeking a highly skilled Process Development Scientist to design, develop, and optimize scientific processes that support product and project goals. This role is responsible for executing experimental strategies, analyzing complex data, and ensuring processes are robust, scalable, and compliant with regulatory standards.

Under general supervision, the Scientist will contribute to process innovation, data-driven decision-making, and continuous improvement initiatives within a cGMP-regulated environment.

This is a hybrid position based in Puerto Rico, operating on an administrative shift schedule.

Key Responsibilities

• Design, develop, and optimize process development strategies to support product lifecycle and manufacturing readiness.
• Execute and evaluate experimental studies; analyze and interpret data to drive process improvements.
• Ensure all studies and activities comply with cGMP, internal procedures, and regulatory guidelines.
• Develop robust and scalable processes through data-driven approaches.
• Author and review technical documentation including scientific reports, protocols, and regulatory submissions.
• Monitor and assess emerging technologies and scientific advancements relevant to process development.
• Collaborate cross-functionally with Manufacturing, Quality, and Engineering teams.
• Troubleshoot process issues and implement effective, innovative solutions.
• Support technology transfer activities and process validation efforts.
• Provide guidance on experimental design and data interpretation.
• Contribute to project timelines and ensure timely completion of deliverables.
• May mentor junior staff and support departmental initiatives such as safety, recruiting, or continuous improvement.

Qualifications

Education

• PhD in a Scientific discipline OR
• Master’s degree + 2 years of relevant experience OR
• Bachelor’s degree + 4 years of relevant experience

Required Skills & Competencies

• Strong knowledge of cGMP regulations and process development principles
• Advanced scientific analysis, troubleshooting, and laboratory skills
• Strong technical writing and documentation skills
• Excellent analytical thinking and problem-solving abilities
• Effective project management and organizational skills
• Strong interpersonal and cross-functional collaboration skills
• Ability to manage multiple priorities in a dynamic environment
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Flexibility and adaptability to evolving priorities

Preferred Qualifications

• Experience in process development, data analysis, or related scientific fields
• Experience working with large and complex datasets
• Proficiency in statistical tools such as:
• R, SAS, MATLAB, JMP, or Minitab
• Knowledge of SQL or database systems
• Experience with statistical modeling (e.g., linear models, multivariate analysis)
• Experience with data visualization and analytics platforms such as:
• OSIsoft PI, Spotfire, OVDAS
• Ability to translate scientific or business questions into data-driven insights
• Experience supporting technology transfer and process validation

Work Environment

• Location: Puerto Rico (local candidates preferred)
• Work Model: Hybrid
• Schedule: Administrative shift

Why Join Us

This role offers the opportunity to work in a high-impact, science-driven environment, contributing to innovative process development while leveraging advanced analytics and scientific expertise to drive meaningful results.