Senior Scientist, Process Development & Validation

fitspr; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

FITS seeks a Validation and Scientist Services professional for the Process Development area. The role requires a Bachelor’s degree and five years of experience in pharmaceutical or regulated industries, with bilingual English/Spanish abilities.

Responsibilities include independent experimentation, data analysis, and leading process validation, tech transfer, and change controls, contributing to a collaborative, ethical lab environment.

Qualifications

• Bachelor's degree with five years of experience as a Scientist in the pharmaceutical or regulated industry.
• Experience in sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
• Experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial processes.

Responsibilities

• Independently monitors or conducts experiments to advance projects or technologies.
• Provides advanced data analysis and interpretation and assesses impact of data on the project.
• Expands knowledge beyond core area of expertise.
• Identifies relevant external competitive knowledge.
• Independently prepares new and novel protocols/experimental designs.
• Leads collaborative efforts and mentoring within the department.

Skills

Bilingual English/Spanish

Project Management

Five years experience as Scientist

Education

Bachelor's degree

Job description

FITS seeks a Validation and Scientist Services professional for the Process Development area. The role requires a Bachelor’s degree and five years of experience in pharmaceutical or regulated industries, with bilingual English/Spanish abilities.

Responsibilities include independent experimentation, data analysis, and leading process validation, tech transfer, and change controls, contributing to a collaborative, ethical lab environment.