Process Development Scientist: Data-Driven Pharma

FITS LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS LLC is seeking a Scientist Services professional for our Process Development: Inspection Projects area in Puerto Rico. The role requires a Bachelor’s degree with four years of experience in pharma, bilingual English/Spanish, and project management skills.

You will work on automated and manual visual inspection, QC of packaging components, GMP line clearance, and data collection in the Process Development Lab.

Qualifications

• Bachelor's degree with four years of experience as a Scientist within the pharmaceutical or regulated industry.
• Bilingual in English and Spanish.
• Project management skills.
• Experience in automated and manual visual inspection of finished drug products.
• Experience with primary packaging components incoming quality inspection (vials, stoppers, caps, syringes).
• GMP packaging line clearance, verification, and in-process controls.
• Process development laboratory sample testing and data collection.

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

Bilingual (English & Spanish)

Project Management

Education

Bachelor's Degree

Job description

FITS LLC is seeking a Scientist Services professional for our Process Development: Inspection Projects area in Puerto Rico. The role requires a Bachelor’s degree with four years of experience in pharma, bilingual English/Spanish, and project management skills.

You will work on automated and manual visual inspection, QC of packaging components, GMP line clearance, and data collection in the Process Development Lab.