Process Development Scientist -05

For Scientist Services in the Process Development: Inspection Projects a rea.

About Flexible & Integrated Technical Services, LLC

• 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!
• 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.
• Automated & Manual Visual Inspection of Finished Drug Products.
• Primary Packaging Components Incoming Quality Inspection (Vials, Stoppers, Caps, Syringes).
• GMP Packaging Line Clearance, Verification, and In-Process Controls.
• Development Laboratory Sample Testing and Data Collection.
• 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.
• AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) 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.

Requirements

• The Technical Part: Bachelor's Degree with four (4) years of experience as a Scientist within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.