Process Scientist

Desired Skills: tech transfers,lifecycle management,regulatory submissions

PE Global is currently recruiting for a Process Scientist for a leading multi-national Pharma client based in Dun Laoghaire.

This is a Hybrid contract position.

Role:

This role offers a unique opportunity to lead and support cutting-edge analytical development efforts. Reporting to the Associate Director of Process Development – Rare Diseases, you will manage the development and maintenance of analytical methodologies in support of commercial and clinical manufacturing.
The assignment includes method development, troubleshooting, transfers, and support across a range of analytical platforms (e.g., Chromatography, CE, General Assays, Gels, Bioassays, and Immunoassays) for various biologic modalities. You will collaborate across internal functions and external partners to support the progress of my clients programs during this fixed-term engagement.

Responsibilities:
• Provide scientific leadership in troubleshooting and addressing analytical challenges, as well as managing method transfers and investigations.
• Lead implementation of fit-for-purpose analytical methods for in-process testing, release, stability, characterization, and regulatory submissions.
• Support cross-functional teams (e.g., ASTLs, product/process teams) by delivering analytical updates, documentation, and data analysis.
• Monitor trends and innovations in analytical sciences and integrate best practices into active projects.
• Ensure timely delivery of milestones related to analytical development, method transfers, and technology implementation.
• Drive decisions on analytical strategy and communicate recommendations, risks, and mitigations to stakeholders and governance teams.
• Represent Attribute Sciences in project teams and liaise with internal groups (e.g., Quality, Regulatory, Manufacturing) and external manufacturing partners.
• Moderate international travel might be required (up to 15% of the time).

Requirements:

• Doctorate degree and 2 years of experience in pharmaceutical/biotech process and product development and analytical method development.
  Master’s degree and 4 years of experience in pharmaceutical/biotech process and product development and analytical method development
  Bachelor’s degree and 8 years of experience in pharmaceutical/biotech process and product development and analytical method development
  Preferred Qualifications:
• D. in Analytical Chemistry, Biochemistry, Chemical Engineering, or related scientific field
• 8+ years in pharmaceutical/biotech analytical development
• Strong knowledge of analytical techniques for biologics and regulatory expectations
• Experience with tech transfers, lifecycle management, and regulatory submissions
• Excellent communication, leadership, and team collaboration skills
• Familiarity with QbD principles and CMC strategy development

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***