Hobson Prior has a new opportunity for a Principal Scientist Analytical Development Gene Therapy to join a fantastic future focused company on a permanent basis in the US. For more information, please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Develop and optimize program-specific assays to quantify rAAV product potency using biochemical and cell-based assays
• Function as CMC-Analytical lead on program teams and interact with external stakeholders on tech transfer activities, assist in troubleshooting method issues and support validation/qualification campaigns
• Maintain and enhance current knowledge of emerging technologies in bio-analytics and biophysical characterization to support improvements for existing analytical strategies and represent us at external events as subject matter expert through presentations and active participation.
• Author and review SOPs, reports and other technical documents and regulatory submissions
• Analyse data with available bioinformatic tools, scientifically-sound interpretation and present the data to internal and external stakeholders.

Key Skills:

• Demonstrated ability to multi-task and be highly productive in a fluid and fast-paced environment.
• A self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
• Ability to communicate and operate effectively within cross-functional teams.
• Proven ability to manage and develop a small team of direct reports.

Requirements:

• The ideal candidate will have a PhD or Master's degree in molecular/cellular biology, cell physiology, biochemistry or related field.
• At least 10 (with a PhD) or 12 years (with a Master's) of relevant analytical development experience in an industry setting.
• In-practice knowledge of the ICH and USP guidelines for assay qualification and validation.
• Demonstrated ability to efficiently develop an assay from concept to a qualified/pre-validated state.
• Extensive hands-on experience in molecular cloning and characterization.
• Experience using flow cytometry, ELISA, HTRF, molecular cell biology and enzymatic methods.
• Extensive experience with experimental design, data analysis organization, and presentation of complex scientific data, integrating this into a validation workflow.
• Experience in developing potency assays and analysis of AAV or similar viral vectors is preferred.
• Experience in mammalian cell culture, cell-based potency assay development, and cell banking is preferred.
• Experience in CMC-Development setting is preferred.
• Experience with analytical or statistical software, e. g., PLA, JMP, Softmax Pro, XLfit, Gen5, etc is preferred.
• Knowledge of and interest in laboratory and equipment automation is preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.