Freelance/Contract Principal Analytical Consultant

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

Freelance/Contract Principal Analytical Consultant

Job Location: United Kingdom

Job Location Type: Remote

Job Contract Type: Full-time

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We are currently partnering with a Biological group as they are urgently seeking a Principal/Senior level Analytical Consultant to help support a key project on a remote basis. This project is to help with their pegylated enzyme protein project and we require SME level in specific areas to fulfil the requirements of this fascinating project. The project is to commence immediately; it can offer work up to 1.0FTE but with some flexibility and it will run for 6 months initially with an extension very likely. It can be performed remote based anywhere within the UK and EU and ideally we would be looking to partner with independent consultants.

Key responsibilities

• Design, implement and manage the analytical strategy for a pegylated enzyme therapeutic program.
• Work across the team as an SME to provide key guidance across the project
• Lead and support SEC-HPMC method development and validation for Phase 3 registration activities
• Assess analytical risks and develop mitigation strategies to support program objectives.
• Key participation within project/scientific teams and offer sound advice/guidance on analytical development strategies
• Overall support the client as and when directed

Skills required

• Ideally educated to a PhD level in a scientific discipline or at least a MSc with substantial experience linked to the project
• Must have a proven SME level in analytical development in the above area
• Hands on experience of SEC-HPLC method development is a must at Phase 3
• 10-15 years experience overall working in the industry (more would also be suitable)
• Proven track record in supporting unlicensed medicines through troubleshooting phases to FDA registration
• Fluent in English
• Can perform the project as set out in the above job description

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.