For the past 20 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. As the world’s largest RCO (Research Consulting Organization), 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.
Job description
ProPharma is currently supporting one of the most exciting Biotech groups within the EU as they are reaching a critical stage of their BLA submission process. At present we are currently looking to partner with an ‘Freelance/Contract Principal Consultant – Analytical Development’ who will be one of their key SME’s to guide them through this critical stage. This project will commence immediately; it requires 1.0 FTE (full time ideally but some flexibility could be given) and it can be performed fully remotely for a period of 6 months with the chance of an extension.
Responsibilities included:
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Lead the creation and implementation of key Analytical Strategies for the assigned product
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Ensure the Analytical writing for critical sections which can include Comparability, Analytical Dev, Reference standard, Stability, Molecular characterization is completed to the necessary standard
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Evaluate key data from these reports and ensure the project objectives are being met
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Writing and evaluating sourcing reports
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Provide SME support to any other area of the project related to Analytical Development when required
Skills required
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Education within a life science or engineering discipline to at least a BSc or higher is a must
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Key exposure to the BLA process from an Analytical development perspective linked to Recombinant proteins is a critical need for this assignment
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Demonstrated experience writing key reports and acting as a SME linked to the above is vital
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Fluent English
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Already based in the EU and can work remotely
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Can perform the project to the designated requirements set out in the job description
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Ideally working as a Freelancer/Independent Consultant already (or immediately available willing to perform a 6 month contract)
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.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Top Skills
What We Do
ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.
With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science
