Scientist, RNA Bioanalytical

We are seeking a Bioanalytical Scientist or Senior Scientist to join the Nonclinical team of a biotech at the forefront of RNA therapeutics development. This person will support Discovery, Preclinical, and Clinical Development programs for bioanalysis and will be responsible for developing and implementing PK and bio analytical strategy for programs, ensuring that PK and bio analytical support is completed in a timely, efficient manner and meets all current scientific and quality standards and adequately supports regulatory submissions.

Responsibilities:

• Utilise significant scientific knowledge for design of bio analytical methods and algorithms to quantify the effect of LNP encapsulated RNAs on specific disease states both in Preclinical and Clinical areas.
• Provide scientific and technical oversight to the bio analytical vendor for work performed at the CRO; manage assay development, transfer, troubleshooting, validation, and analysis of biological samples to support drug discovery & development for various candidates using LC-MS/MS, hybrid LC-MS/MS, qPCR, cell-based and ligand binding assays (ELISA, IHC) etc. at CRO.
• Manage and resolve any problems or issues while keeping team and management informed of critical issues in a timely manner.
• Responsible for ensuring reports are complete and accurate and meet regulatory filing requirements.
• Responsible for preparing and/or providing input on Clinical/Non-Clinical regulatory documents including protocols, protocol amendments, reports, IBs, publications and presentations, and regulatory filings including IND etc., briefing books, and responses to questions from regulatory agencies.
• Expected to advise teams and management continuously and proactively on the development and optimisation of bioanalytical technologies, strategies and models to improve the quality and productivity of the function.
• Will be a member of the Early Development/Nonclinical Safety group but will partner with colleagues in other functional areas such as Clinical Operations/Development etc. as needed to identify and manage external vendor support of GLP/GCP sample analysis.
• Will also be required to stay current with the latest in technological and regulatory advances in the bio analytical realm.

Qualifications:

• BS or MS with several years of experience
• Strong expertise in FDA/EMA, GLP/GCP regulatory requirements and both Clinical & Non-Clinical bio analytical data management (both GLP and non-GLP) including data transferring, analysis, and reporting.
• Prior experience with laboratory and vendor management is required.
• Strong organisation, multi-tasking and communication skills are key attributes of the successful candidate.
• Individuals with regulatory writing experience in the context of bio analytical sciences, and having first-author, peer reviewed publications and/or presentations will be strong candidates for this role.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 857-362-9542 or m.robinson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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