Process Development Sr Scientist

FITS, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS, LLC is seeking a Validation and Scientist Services professional for Process Development. The role requires a Bachelor’s degree and at least five years of experience in sterile drug product manufacturing, aseptic filling, and process validation within the pharmaceutical industry.

The candidate will independently conduct experiments, analyze data, develop new protocols, and collaborate across teams to advance projects.

Qualifications

• Bachelor's degree with 5 years' experience as a Scientist in pharma/regulated industry.
• Experience in sterile drug product manufacturing and aseptic filling operations.
• Knowledge of process characterization, PPQ validation, technology transfer, and commercial process.
• Experience executing validation protocols, characterization studies, technical reports, investigations, and change controls.

Responsibilities

• Independently monitors or conducts experiments to advance projects.
• Provides advanced data analysis and interpretation, and assesses data impact on the project.
• Expands knowledge beyond core area and identifies external competitive knowledge.
• Independently prepares new and novel protocols/experimental designs.
• Leads department-wide support efforts such as safety, recruiting and committees.
• Plans detailed procedures for defined projects, including timelines and resources.

Skills

Lab data analysis

Independent experiments

Collaborations

Technical reporting

Education

Bachelor's degree in science

Job description

For Validation and Scientist Services in the Process Development a rea.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with five(5)years of experience asa Scientistwithin the pharmaceutical or regulated industry.
• Shift: Administrative, and according to business needs.
• Experience in:
  • Sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
  • Aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process.
  • Executing validation protocols, characterization studies, technical reports, investigations, and change controls.

The Personality Part:

• Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, and creative (forcomingup with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork,ethical behavior, and the use ofthe scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies.
• Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations.
• Expands knowledge-seeking beyond core area of expertise.
• Identifies relevant external competitive knowledge.
• Independently prepares new and novel protocols/experimental design.
• Key contributor to an independent research/project team.
• Initiates productive collaborations outside of the department or company.
• Introduces new or advanced technologies and/or concepts.
• May contribute to scientific journal articles or complex technical documents as lead author.
• Leads department-wide support efforts such as safety, recruiting and committees. Develops supervisory and mentoring skills.
• Makes proactive decisions that contribute to the achievement of milestones.
• Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!