Principal Analytical Consultant (Biotech)

TL;DR

Principal Analytical Consultant (Biotech): Designing and managing the analytical strategy for a pegylated enzyme therapeutic program with an accent on SEC-HPLC method development and validation for Phase 3 registration. Focus on providing SME-level guidance, troubleshooting analytical risks, and supporting unlicensed medicines through the FDA registration process.

Location: Must be based in the UK or EU (Remote/Hybrid).

Company

hirify.global provides expert consulting and operational support to biotech, med device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Design, implement, and manage the analytical strategy for a pegylated enzyme therapeutic program.
• Provide SME-level guidance and technical leadership across the project team.
• Lead SEC-HPLC method development and validation activities for Phase 3 registration.
• Assess analytical risks and develop mitigation strategies to ensure program objectives are met.
• Participate in scientific team meetings to offer sound advice on analytical development strategies.
• Support the client with technical troubleshooting and regulatory guidance as directed.

Requirements

• Must be based in the UK or EU.
• PhD in a scientific discipline preferred, or MSc with substantial relevant experience.
• 10-15+ years of industry experience in analytical development.
• Proven hands-on experience with SEC-HPLC method development at Phase 3.
• Demonstrated track record in supporting unlicensed medicines through troubleshooting to FDA registration.
• English: Fluent proficiency required.

Culture & Benefits

• Opportunity to work on a high-profile, fascinating biological project.
• Flexible working arrangements with up to 1.0 FTE commitment.
• Initial 6-month contract with a high likelihood of extension.
• Commitment to diversity, equity, and inclusion in a collaborative work environment.
• Supportive culture that values authentic self-expression and innovation.