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Process Development Sr Scientist

fitspr

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

About fitspr

  • Picture as well an environment of healthy competition, teamwork, ethical behavior, and the use of the scientific method in all ways possible.
  • If you like how this sounds, then this might be the job for you.
  • Bring it on!
  • Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources.
  • We are a Service Provider company different 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 industry clients with top-notch quality talent.
  • We're FITS!
  • Are you the next piece?

Responsibilities

  • Administrative, and according to business needs.
  • 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.
  • 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.
  • 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.
  • 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.

Requirements

  • The Technical Part: Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry.
  • Bilingual (English & Spanish).
  • Project Management skills.
  • Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, and creative (for coming up with all those experiments!) skills to work.
  • May contribute to scientific journal articles or complex technical documents as lead author.

Preferred

  • Identifies relevant external competitive knowledge.