Remote Organon Site CMC Associate Principal Scientist

This job has been removed

Location: New Jersey, Pennsylvania

Compensation: Salary

Staff Reviewed: Thu, Jan 21, 2021

This job expires in: 25 days

Job Category: Healthcare

Remote Level: Partially Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A global biopharmaceutical company has a current position open for a Remote Organon Site CMC Associate Principal Scientist.

Core Responsibilities Include:

  • Manage the interface between the Manufacturing Site and Regulatory CMC
  • Ensure that the information included in global regulatory submissions/filings is aligned to plant information
  • Ensure that regulatory-impacting changes are correctly identified and assessed for regulatory impact

Skills and Requirements Include:

  • Travel Requirements: 10%
  • Bachelor’s degree or higher in science, (e.g. pharmacy, chemistry, biotechnology, microbiology, biomedical sciences, etc.)
  • 3 years’ experience in CMC Regulatory Affairs for pharmaceutical or biotechnology products
  • 5 years of experience in the pharmaceutical industry in a regulatory, compliance, technical services or quality role
  • Must be able to effectively manage the competing demands of site and corporate stakeholders
  • Must have good understanding of and experience working in a busy commercial manufacturing organization

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