Principal Analytical Consultant (Biotech)

Location: Remote anywhere within the United Kingdom and European Union

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Design, implement, and manage the analytical strategy for a pegylated enzyme therapeutic program.
• Serve as a subject matter expert and provide analytical development guidance across the project.
• Lead and support SEC-HPLC method development and validation for Phase 3 registration activities.
• Assess analytical risks and develop mitigation strategies aligned with program objectives.
• Participate in scientific and project teams and provide advice on analytical development strategies.
• Support the client with analytical activities as directed.

Requirements

• PhD in a scientific discipline preferred, or MSc with substantial relevant experience.
• SME-level expertise in analytical development for pegylated enzyme proteins or a closely related area.
• Hands-on SEC-HPLC method development experience at Phase 3 is required.
• 10–15 years of industry experience; more experience is also suitable.
• Proven experience supporting unlicensed medicines through troubleshooting phases to FDA registration.
• Fluent English is required.

Culture & Benefits

• Remote project engagement available across the UK and EU.
• Initial six-month project with a strong likelihood of extension.
• Workload of up to 1.0 FTE with some flexibility.
• Independent consultants are preferred for this engagement.
• Commitment to diversity, equity, inclusion, and an authentic, collaborative workplace.
• Remote working is supported, with optional hybrid collaboration for hires located within a reasonable commute of an office.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applicants receive an outcome after the application review.