Freelance/Contract Principal Analytical Consultant
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.
The Project
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
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