Senior Analytical Consultant - Pegylated Enzymes (Remote)

Lifelancer Ltd; United States; Remote; USD 119,000 - 185,000; Full time

Job summary

ProPharma is seeking a Principal/Senior Analytical Consultant for a remote, UK/EU-based engagement. The project runs up to 1.0 FTE for 6 months with potential extension, focusing on a pegylated enzyme program.

You will design analytical strategies, act as SME across the team, and lead SEC-HPLC method development for Phase 3 activities while coordinating risk mitigation and regulatory support.

Qualifications

• Must have PhD (or MSc with substantial relevant experience) in a scientific discipline.
• Proven SME level in analytical development for pegylated enzyme projects.
• Hands-on SEC-HPLC method development experience, Phase 3 of regulatory program.
• 10-15 years of industry experience, higher also suitable.
• Track record of supporting unlicensed medicines through troubleshooting to FDA registration.
• Fluent English, able to operate in a global remote setup.

Responsibilities

• Design and manage the analytical strategy for the pegylated enzyme program.
• Serve as SME to provide guidance across the project team.
• Lead and support SEC-HPLC method development and validation for Phase 3 registration activities.
• Assess analytical risks and develop mitigation strategies to meet program objectives.
• Participate in project/scientific teams and provide actionable guidance on analytical strategies.
• Support the client operations remotely as directed.

Skills

PhD in science

SME in analytics

SEC-HPLC method development

10-15 years experience

FDA registration support

Fluent in English

Education

PhD in scientific discipline

MSc with substantial project experience

Tools

SEC-HPLC

Job description

ProPharma is seeking a Principal/Senior Analytical Consultant for a remote, UK/EU-based engagement. The project runs up to 1.0 FTE for 6 months with potential extension, focusing on a pegylated enzyme program.

You will design analytical strategies, act as SME across the team, and lead SEC-HPLC method development for Phase 3 activities while coordinating risk mitigation and regulatory support.