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PROCESS DEVELOPMENT SPECIALIST

Caguas, PR
PROCESS DEVELOPMENT SPECIALIST
 

Description

Seeking a Process Development Specialist that have a statistical background. THE PROCESS DEVELOPMENT SPECIALIST 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
  • KNOWLEDGE IN FILLING PROCESS
  • KNOWLEDGE IN GRANULATION AND COMPRESSION OF SOLID DOSAGE
  • KNOWLEDGE IN PARENTERAL FORMULATION
  • EXPERIENCE WITH MINITAB
  • 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

 Bachelor's degree and 5 years of experience . RELATED EXPERIENCE IN THE PHARMACEUTICAL, BIOTECHNOLOGY OR MEDICAL DEVICES INDUSTRY
 
Integrated Technology and Compliance Services is an Equal Opportunity Employer

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