Title: Process Development Scientist – Job ID 35500

Location: Juncos, Puerto Rico (Open to Puerto Rico Residents)

Work Schedule: Onsite | Administrative Shift (Availability for shifts based on project needs)

Position Summary

Our client is seeking a Process Development Scientist to conceive, design, implement, and execute scientific experiments that contribute to the successful completion of projects and organizational goals under the general guidance of a supervisor.

The selected candidate will support process development initiatives by designing experimental strategies, analyzing and interpreting scientific data, developing technical documentation, and ensuring all studies are conducted in compliance with applicable protocols, regulatory requirements, and cGMP standards.

Preferred Qualifications

• Bachelor's, Master's, or Doctoral degree in a scientific discipline.
• Chemical Engineering or Mechanical Engineering is preferred, but not required.
• Experience in drug product manufacturing.
• Experience supporting process validation activities.
• Experience writing technical protocols and scientific reports.

Key Responsibilities

Scientific Research & Process Development

• Conceive, design, execute, evaluate, and interpret scientific experiments and experimental strategies.
• Provide input into new processes to generate robust and reliable scientific data.
• Design, monitor, or conduct experimental strategies under the general guidance of a supervisor.
• Develop and implement new and innovative scientific protocols to address technical challenges.
• Introduce advanced scientific methods when appropriate.
• Apply scientific theory to the design, execution, and interpretation of experimental results.

Data Analysis & Technical Support

• Analyze and interpret experimental data and assess its impact on project objectives.
• Advise and assist colleagues with experimental design, data interpretation, and implementation of innovative solutions.
• Monitor scientific literature and emerging technologies relevant to the area of expertise and communicate significant findings.
• Maintain current knowledge of scientific advancements applicable to assigned responsibilities.

Documentation & Regulatory Compliance

• Ensure all studies are conducted in accordance with approved protocols, applicable guidelines, regulatory requirements, and cGMP standards.
• Independently author scientific reports, summary documents, complex regulatory documents, invention disclosure submissions, and patent-related documentation, as applicable.
• Prepare technical protocols and scientific documentation supporting project objectives.

Cross-Functional Collaboration

• Represent the department on project teams under the guidance of senior scientific staff.
• Develop productive collaborations within and outside the department or organization.
• Work effectively with cross-functional teams to support project execution and scientific initiatives.
• Develop and manage project timelines to ensure timely completion of assigned work.

Leadership & Professional Development

• Participate in the external scientific community when appropriate.
• Support department-wide initiatives such as safety programs, recruiting efforts, and committee participation.
• Develop mentoring and supervisory skills while supporting team objectives.

Minimum Education and Experience

Candidates must meet one of the following qualifications:

• Doctorate degree
• Master's degree with 2 years of scientific experience
• Bachelor's degree with 4 years of scientific experience

Required Knowledge and Skills

• Advanced scientific analysis and technical troubleshooting skills.
• Advanced laboratory experience.
• Strong understanding of scientific principles and experimental design.
• Experience applying scientific theory to research and process development.
• Strong analytical and problem-solving skills.
• Technical writing experience, including scientific reports and protocols.
• Excellent verbal and written communication skills.
• Project management and organizational skills with the ability to manage multiple priorities.
• Negotiation and conflict resolution skills.
• Ability to work collaboratively across multiple departments.
• Flexibility and ability to adapt to changing priorities.
• Proficiency with Microsoft Windows applications, including Word, Excel, and PowerPoint.
• Strong knowledge of current Good Manufacturing Practices (cGMP).
• Fully bilingual in English and Spanish.