Global Analytical Scientist, Method Transfers & Compliance

Morgan McKinley

Dublin

On-site

EUR 85,000 - 105,000

Full time

4 days ago
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Job summary

Morgan McKinley is seeking a Scientist to oversee analytical operations across the commercial product portfolio. Reporting to the Principal Scientist, you will manage transfers and validations, drive change controls, and coordinate external CMOs and partner labs to ensure regulatory filings and product release readiness.

This role requires strong cross-functional collaboration across global teams, adherence to cGMP/GDP standards, and a proactive approach to continuous improvement and quality in

Qualifications

  • Bachelors degree in Chemistry or related scientific discipline.
  • Minimum of 5 years in Quality, Compliance, or Technical Operations in a regulated environment.
  • Solid understanding of the commercial analytical lifecycle and regulatory expectations (cGMP/GDP).

Responsibilities

  • Lead and support analytical method transfers and validations in GMP QC laboratories (internal and external).
  • Manage and support global analytical change controls related to method updates and regulatory filings.
  • Support operational relationships with external testing facilities for commercial product manufacturing and batch release.
  • Coordinate cross-functional, remote, and multi-site teams across global regions with a focus on compliance and timely problem resolution.
  • Foster a collaborative, quality-focused work environment with open communication and continuous development.

Skills

Analytical testing
Cross-functional collaboration
Project leadership
Team engagement
Regulatory knowledge

Education

Bachelor's degree in Chemistry or Biological Sciences

Job description

Morgan McKinley is seeking a Scientist to oversee analytical operations across the commercial product portfolio. Reporting to the Principal Scientist, you will manage transfers and validations, drive change controls, and coordinate external CMOs and partner labs to ensure regulatory filings and product release readiness.

This role requires strong cross-functional collaboration across global teams, adherence to cGMP/GDP standards, and a proactive approach to continuous improvement and quality in

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