Process Development Principal Scientist

Inteldot has over 11 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. 

Description: 

To develop projects/programs and contribute to novel experimental strategies and scientific vision. Functions as a lead scientific resource with cross-functional impact. Capable of managing and leading scientific projects which may involve cross functional areas.

Competencies / Skills: 

• Experience in Combination Products or Medical Devices
• Characterization and Validation experience
• Development of Characterization and Validation protocols
• Execution of Characterization and Validation protocols
• Device assembly equipment and packaging equipment validation experience

 Responsibilities: 

• Working knowledge of pharmaceutical/biotech processes. 
• Familiarity with documentation in a highly regulated environment.
• Ability to operate specialized laboratory equipment and computers as appropriate. 
• Ability to interpret and apply GLPs and GMPs. 
• Able to develop solutions to routine technical problems of limited scope.
• Demonstrated skills in the following areas: 
  • Problem solving and applied engineering, Basic technical report writing, Verbal communication,
• Demonstrated Skills in the following areas:
  • Basic technical presentations, Personal Organization, Dealing with and managing change, Technical (Equipment Specific), Analytical Problem Solving, Computer Literacy, Specialized equipment/process expertise, Interacts effectively with variety of communication and working styles.
• Ability to independently determine when additional internal resources are required to solve problems, Ability to handle multiple projects at one time.
• Demonstrated Skills in the following areas:
  • Schedule development, Facilitation, Collaboration. Completion and follow-up. Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.

Education: 

Master degree and 6 years of Scientific experience or Bachelor degree and 8 years Scientific experience
Mechanical Engineering, Industrial Engineering, Chemical Engineering, Electrical
Engineering, or Scientist