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Sr. Process Scientist

Juncos, PR
SR. PROCESS SCIENTIST
 
Description
 
Seeking a Process Scientist that have experience as process engineer and experience in process validation, NC investigations and technology transfer. Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry.

Responsibilities
  • Conceives and designs, executes or 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.
  • Provides data analysis and interpretation and assesses impact of the data on the project.
  • Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
  • Participates in external scientific community. May assume 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 team work.

Skills and Qualifications
  • EXPERIENCE WITH CHANGE CONTROL AND PROJECT MANAGEMENT
  • EXPERIENCE IN PROCESS VALIDATIONS AND TECHNOLOGY TRANSFER
  • Basic Project Management
  • Problem solving skills
  • Negotiation, persuasion, facilitation and project cost development skills.
  • Manage multiple tasks
  • Able to work independently
  • Strong oral and written communication skills.
  • Fully bilingual (English and Spanish)
  • Facilitates and organizes
  • Microsoft Office

Requirements
 
Master's Degree in Life Sciences or Engineering and 3 years of Scientific experience or Bachelor's Degree in Life Sciences or Engineering and 5 years of Scientific experience.

Integrated Technology and Compliance Services is an Equal Opportunity Employer

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