GMP Analytical Scientist: Method Transfers & Validation

Next Generation

Carlow

On-site

EUR 42,000 - 60,000

Full time

6 days ago
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Job summary

Next Generation is seeking an Associate Specialist in Site Analytical Sciences to work in a GMP-regulated pharmaceutical lab. You will perform analytical testing, support method transfers and validations, and help manage the lifecycle of analytical methods.

The role requires 2–3 years of relevant experience, hands-on use of HPLC/UHPLC, Empower Software, and data integrity practices. Collaboration across QC, Manufacturing, and Validation teams is expected.

Qualifications

  • Bachelor's degree in Analytical Chemistry or related field.
  • 2–3 years of relevant experience in pharmaceutical analytics.
  • Experience in GMP-regulated laboratories.
  • Hands-on analytical testing with HPLC/UHPLC and related techniques.
  • Experience reviewing analytical data and technical documentation.

Responsibilities

  • Perform GMP-based analytical testing and studies.
  • Lead method transfers, validations, and verifications.
  • Support lifecycle management of analytical methods.
  • Generate, review, and interpret analytical data.
  • Prepare technical reports and documentation.
  • Troubleshoot methods and equipment.
  • Support equipment qualification activities.
  • Contribute to investigations and CAPAs.
  • Collaborate with QC, Manufacturing, Validation, and Global teams.
  • Maintain data integrity and regulatory compliance.

Skills

Analytical mindset
Technical report writing
Communication skills
Organisational skills

Education

Bachelor's Degree in Analytical Chemistry

Tools

HPLC/UHPLC
Empower Software
CE-SDS
icIEF
ELISA
Cell-based assays

Job description

Next Generation is seeking an Associate Specialist in Site Analytical Sciences to work in a GMP-regulated pharmaceutical lab. You will perform analytical testing, support method transfers and validations, and help manage the lifecycle of analytical methods.

The role requires 2–3 years of relevant experience, hands-on use of HPLC/UHPLC, Empower Software, and data integrity practices. Collaboration across QC, Manufacturing, and Validation teams is expected.

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