Process Development Scientist: Formulation & Data Strategy

FITS LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Scientist for Process Development: Inspection Projects to design and execute experiments, generate robust data, and ensure compliant studies. The role emphasizes deviations investigations, data analysis, and collaboration with senior staff to advance projects.

You should hold a Bachelor's degree with 4 years of experience in pharma or regulated settings and be bilingual in English and Spanish, with strong project management skills for cross-functional teams.

Qualifications

• Bachelor's degree with 4 years of experience as a Scientist in the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project management skills.
• Experience in formulation and aseptic filling operations.
• Process monitoring, data trending, and statistical analysis tools.
• Deviations, investigations, root cause analysis, and product impact assessments.

Responsibilities

• Conceives, designs, executes, evaluates, and interprets experimental strategies.
• Provides input to new processes to generate robust and reliable data.
• Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
• Designs, monitors, or conducts experimental strategies with general guidance from the supervisor.
• Provides data analysis and interpretation and assesses the impact of the data on the project.
• Keeps current in the field of scientific expertise and areas relevant to their function.
• Monitors field of expertise, including literature and technology development, and communicates relevant observations.
• May introduce advanced scientific methods.
• Develops and implements new and novel protocols to address specific issues.
• May represent the department on project teams under the supervision of a senior scientific staff member.
• May initiate productive collaborations within and outside of the department or company.
• Advises or assists others in experimental design and/or interpretation/diagnosis of data and implements innovative remedies.
• Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions, and/or patents.
• Participates in the external scientific community.
• May assume a lead role in department-wide support efforts such as safety, recruiting, and committees.
• May develop supervisory and mentoring skills.
• Develops and follows timelines for completing project teamwork.

Skills

Project management

Bilingual (English & Spanish)

Education

Bachelor's degree

Tools

Statistical analysis tools

Job description

FITS LLC in Puerto Rico seeks a Scientist for Process Development: Inspection Projects to design and execute experiments, generate robust data, and ensure compliant studies. The role emphasizes deviations investigations, data analysis, and collaboration with senior staff to advance projects.

You should hold a Bachelor's degree with 4 years of experience in pharma or regulated settings and be bilingual in English and Spanish, with strong project management skills for cross-functional teams.