обновлено 1 месяц назад
Principal Analytical Consultant (Biotech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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, validation, and Phase 3 registration activities. Focus on assessing analytical risks, developing mitigation strategies, and providing SME guidance through troubleshooting and FDA registration.
Location: Remote anywhere within the United Kingdom and European Union
Company
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.
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